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

Antisera, Control For Nontreponemal Tests

21 CFR 866.3820 / Microbiology
FDA source (opens on fda.gov)

GMP is the FDA product code for Antisera, Control For Nontreponemal Tests, a class II device type, regulated under 21 CFR 866.3820. As of , FDA records hold 9 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
GMP
Device name
Antisera, Control For Nontreponemal Tests
Regulation
21 CFR 866.3820
Device class
Class II
Review panel
Microbiology
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
Yes
Ingested clearances
9
Ingested recalls
0

Clearances, product code GMP

By decision year
9 clearances under product code GMP with a decision year between 1981 and 1998, 1981 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code GMP by decision year
YearClearances
19812
19841
19851
19881
19891
19962
19981

Applicants with the most clearances

Product code GMP
Applicants holding the most 510(k) clearances under product code GMP
ApplicantClearances
Allelix Diagnostics, Inc.1
Ampcor Diagnostics, Inc.1
Beckman Instruments, Inc.1
Biokit USA, Inc.1
Consolidated Technologies, Inc.1
Hillside Acres, Inc.1
Ncs Diagnostics, Inc.1
Remel, L.P.1
Texas Immunology, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code