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

Antiserum, Fluorescent, Mumps Virus

21 CFR 866.3380 / Microbiology
FDA source (opens on fda.gov)

GRA is the FDA product code for Antiserum, Fluorescent, Mumps Virus, a class I device type, regulated under 21 CFR 866.3380. As of , FDA records hold 3 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
GRA
Device name
Antiserum, Fluorescent, Mumps Virus
Regulation
21 CFR 866.3380
Device class
Class I
Review panel
Microbiology
Submission type
510(k) exempt
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
3
Ingested recalls
0

Clearances, product code GRA

By decision year
3 clearances under product code GRA with a decision year between 1977 and 1989, 1977 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code GRA by decision year
YearClearances
19771
19821
19891

Applicants with the most clearances

Product code GRA
Applicants holding the most 510(k) clearances under product code GRA
ApplicantClearances
Bion Ent., Ltd.1
Electro-Nucleonics Laboratories, Inc.1
Flow Laboratories, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code