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

Cells, Animal And Human, Cultured

21 CFR 864.2280 / Hematology
FDA source (opens on fda.gov)

KIR is the FDA product code for Cells, Animal And Human, Cultured, a class I device type, regulated under 21 CFR 864.2280. As of , FDA records hold 170 510(k) clearances under this code, the most recent dated , and one recall.

Classification record

Product code
KIR
Device name
Cells, Animal And Human, Cultured
Regulation
21 CFR 864.2280
Device class
Class I
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
170
Ingested recalls
1

Clearances, product code KIR

By decision year
170 clearances under product code KIR with a decision year between 1978 and 1997, 1993 the highest year at 36.
Show the numbers
510(k) clearances under FDA product code KIR by decision year
YearClearances
19781
198310
198430
198514
19867
19872
19902
199215
199336
199433
19952
19969
19979

Applicants with the most clearances

Product code KIR
Applicants holding the most 510(k) clearances under product code KIR
ApplicantClearances
Proteins Intl., Inc.51
Viromed Laboratories, Inc.22
Advanced Clinical Diagnostics18
Earl-Clay Laboratories, Inc.17
Neogenex15
Ortho-Clinical Diagnostics, Inc.13
Bartels Immunodiagnostic Supplies, Inc.10
Genus Diagnostics8
Biocon, Inc.3
Difco Laboratories, Inc.3

Companies listing this code with FDA

Companies whose registered establishments list this code