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

Substance, Blood Grouping Of Non-Human Origin For In Vitro Diagnostic Use

21 CFR 864.9160 / Hematology
FDA source (opens on fda.gov)

KSX is the FDA product code for Substance, Blood Grouping Of Non-Human Origin For In Vitro Diagnostic Use, a class II device type, regulated under 21 CFR 864.9160. As of , FDA records hold 8 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
KSX
Device name
Substance, Blood Grouping Of Non-Human Origin For In Vitro Diagnostic Use
Regulation
21 CFR 864.9160
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
8
Ingested recalls
0

Clearances, product code KSX

By decision year
8 clearances under product code KSX with a decision year between 1977 and 1980, 1978 the highest year at 3.
Show the numbers
510(k) clearances under FDA product code KSX by decision year
YearClearances
19772
19783
19803

Applicants with the most clearances

Product code KSX
Applicants holding the most 510(k) clearances under product code KSX
ApplicantClearances
North American Biologicals, Inc.3
Gamma Biologicals, Inc.2
Ortho Diagnostics, Inc.2
Travenol Laboratories, S.A.1

Companies listing this code with FDA

Companies whose registered establishments list this code