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

Sera, Animal And Human

21 CFR 864.2800 / Hematology
FDA source (opens on fda.gov)

KIS is the FDA product code for Sera, Animal And Human, a class I device type, regulated under 21 CFR 864.2800. As of , FDA records hold 45 510(k) clearances under this code, the most recent dated , and one recall.

Classification record

Product code
KIS
Device name
Sera, Animal And Human
Regulation
21 CFR 864.2800
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
45
Ingested recalls
1

Clearances, product code KIS

By decision year
45 clearances under product code KIS with a decision year between 1978 and 1988, 1981 the highest year at 15.
Show the numbers
510(k) clearances under FDA product code KIS by decision year
YearClearances
19781
19802
198115
19831
19841
19851
198611
198710
19883

Applicants with the most clearances

Product code KIS
Applicants holding the most 510(k) clearances under product code KIS
ApplicantClearances
Hyclone Laboratories, Inc.10
Dutchland Laboratories, Inc.9
Hazleton Research Products, Inc.9
Biolabs, Inc.3
Flow Laboratories, Inc.2
Amf Biological and Diagnostics Co.1
Animal Health Laboratories, Inc.1
Candace Lane Corp.1
Cell Culture Laboratories1
Dextran Products, Ltd.1

Companies listing this code with FDA

Companies whose registered establishments list this code