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510(k) clearances

Profoject™ Safety Sliding Blood Collection Set

CMT Health PTE., Ltd. · Clinical Chemistry

K262215Substantially EquivalentTraditionalJKA
Open FDA's page for this record
Third party flag
N
City
Singapore
Advisory committee description
Clinical Chemistry
Address 1
6001 Beach Rd., #19-13a, Golden Mile Tower
Statement or summary
Summary
Product code
JKA
Zip code
199589
Applicant
CMT Health PTE., Ltd.
Decision date
2026-09-25
Decision code
SESE
Country code
SG
Device name
Profoject™ Safety Sliding Blood Collection Set
Advisory committee
CH
Contact
Monica Ma
K number
K262215
Date received
2026-06-30
Review advisory committee
HO
Postal code
199589
Decision description
Substantially Equivalent
Clearance type
Traditional
Harmonized identifiers (openFDA)
Device name
Tubes, Vials, Systems, Serum Separators, Blood Collection
Medical specialty description
Clinical Chemistry
Regulation number
862.1675
Device class
2
Registration number
3030733800, 3007829657, 3012187973, 3007135420, 3030626857, 3030446844, 3012552122, 3015173212, 3019004087, 9680448, 3003744503, 3031789039, 2030624, 2321034, 3027553380, 3012536737, 3014579161, 3028019212, 8021764, 8020040, 3015997711, 9681572, 3022964615, 2648045, 3003974574, 3034667025, 3015276780, 3041276591, 3002682307, 3016904853, 3035708936, 3012104670, 3011287770, 9617604, 1911916, 3013557562, 3043226252, 1423507, 3009742443, 3010352064 +183 more
FEI number
3030733800, 3007829657, 3003560965, 3003992026, 3012187973, 3007135420, 3030626857, 3030446844, 3012552122, 1000306068, 3015173212, 3019004087, 3003744503, 3031789039, 3002807725, 3027553380, 3002836339, 3012536737, 3014579161, 3028019212, 3002558692, 3015997711, 3022964615, 3001451226, 1000442352, 2648045, 3003974574, 3034667025, 3015276780, 3041276591, 3002682307, 3016904853, 3035708936, 1000374126, 3012104670, 3011287770, 3001451379, 1911916, 3013557562, 3043226252 +183 more
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Data from openFDA, FDA's public API. FDA says not to rely on it to make decisions about medical care and to treat every result as unvalidated; confirm against FDA's own record and the product labeling. Not medical or legal advice.