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

Antiserum, Cf, Epstein-Barr Virus

21 CFR 866.3235 / Microbiology
FDA source (opens on fda.gov)

GNP is the FDA product code for Antiserum, Cf, Epstein-Barr Virus, a class I device type, regulated under 21 CFR 866.3235. As of , FDA records hold 20 510(k) clearances under this code, the most recent dated , and 2 recalls.

Classification record

Product code
GNP
Device name
Antiserum, Cf, Epstein-Barr Virus
Regulation
21 CFR 866.3235
Device class
Class I
Review panel
Microbiology
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
Yes
Ingested clearances
20
Ingested recalls
2

Clearances, product code GNP

By decision year
20 clearances under product code GNP with a decision year between 1977 and 2002, 1986 the highest year at 3.
Show the numbers
510(k) clearances under FDA product code GNP by decision year
YearClearances
19771
19811
19852
19863
19873
19882
19892
19901
19992
20023

Applicants with the most clearances

Product code GNP
Applicants holding the most 510(k) clearances under product code GNP
ApplicantClearances
Pan Bio Pty., Ltd.3
Amico Lab, Inc.2
Diagnostic Technology, Inc.2
Diamedix Corp.2
Granbio, Inc.2
IMMUNO CONCEPTS, NA, Ltd.2
Biotech Research Laboratories, Inc.1
Electro-Nucleonics Laboratories, Inc.1
Electro-Nucleonics, Inc.1
Gull Laboratories, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code