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

Solution, Stabilized Enzyme

21 CFR 864.9400 / Hematology
FDA source (opens on fda.gov)

KSK is the FDA product code for Solution, Stabilized Enzyme, a class II device type, regulated under 21 CFR 864.9400. As of , FDA records hold 5 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
KSK
Device name
Solution, Stabilized Enzyme
Regulation
21 CFR 864.9400
Device class
Class II
Review panel
Hematology
Submission type
510(k) exempt
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
5
Ingested recalls
0

Clearances, product code KSK

By decision year
5 clearances under product code KSK with a decision year between 1976 and 1982, 1982 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code KSK by decision year
YearClearances
19761
19781
19811
19822

Applicants with the most clearances

Product code KSK
Applicants holding the most 510(k) clearances under product code KSK
ApplicantClearances
Biological Corp. of America2
BD Becton Dickinson Vacutainer Systems Preanalytic1
Gamma Biologicals, Inc.1
Hyland Therapeutic Div., Travenol Laboratories1

Companies listing this code with FDA

Companies whose registered establishments list this code