510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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KSFClass II

Kit, Quality Control For Blood Banking Reagents

21 CFR 864.9650 / Hematology
FDA source (opens on fda.gov)

KSF is the FDA product code for Kit, Quality Control For Blood Banking Reagents, a class II device type, regulated under 21 CFR 864.9650. As of , FDA records hold 12 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
KSF
Device name
Kit, Quality Control For Blood Banking Reagents
Regulation
21 CFR 864.9650
Device class
Class II
Review panel
Hematology
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
12
Ingested recalls
0

Clearances, product code KSF

By decision year
12 clearances under product code KSF with a decision year between 1977 and 1981, 1980 the highest year at 4.
Show the numbers
510(k) clearances under FDA product code KSF by decision year
YearClearances
19772
19782
19792
19804
19812

Applicants with the most clearances

Product code KSF
Applicants holding the most 510(k) clearances under product code KSF
ApplicantClearances
Ortho Diagnostics, Inc.2
American Dade1
Bca Biological Corp. of America1
BD Becton Dickinson Vacutainer Systems Preanalytic1
Dade, Baxter Travenol Diagnostics, Inc.1
Diagnostic Technology, Inc.1
Gamma Biologicals, Inc.1
Gotham Biologics, Inc.1
Hyland Therapeutic Div., Travenol Laboratories1
North American Biologicals, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 18 companies shown, in name order