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

Media, Potentiating For In Vitro Diagnostic Use

21 CFR 864.9600 / Hematology
FDA source (opens on fda.gov)

KSG is the FDA product code for Media, Potentiating For In Vitro Diagnostic Use, a class II device type, regulated under 21 CFR 864.9600. As of , FDA records hold 13 510(k) clearances under this code, the most recent dated , and one recall.

Classification record

Product code
KSG
Device name
Media, Potentiating For In Vitro Diagnostic Use
Regulation
21 CFR 864.9600
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
13
Ingested recalls
1

Clearances, product code KSG

By decision year
13 clearances under product code KSG with a decision year between 1978 and 1981, 1979 the highest year at 5.
Show the numbers
510(k) clearances under FDA product code KSG by decision year
YearClearances
19784
19795
19802
19812

Applicants with the most clearances

Product code KSG
Applicants holding the most 510(k) clearances under product code KSG
ApplicantClearances
Biological Corp. of America3
Ortho Diagnostics, Inc.2
BD Becton Dickinson Vacutainer Systems Preanalytic1
Dade, Baxter Travenol Diagnostics, Inc.1
Fisher Scientific Company L.L.C.1
Gamma Biologicals, Inc.1
Gotham Biologics, Inc.1
Hyland Therapeutic Div., Travenol Laboratories1
Miles Laboratories, Inc.1
Pfizer Inc1

Companies listing this code with FDA

Companies whose registered establishments list this code