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

Antiserum, Fluorescent, Rubeola

21 CFR 866.3520 / Microbiology
FDA source (opens on fda.gov)

GRE is the FDA product code for Antiserum, Fluorescent, Rubeola, a class I device type, regulated under 21 CFR 866.3520. As of , FDA records hold 4 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
GRE
Device name
Antiserum, Fluorescent, Rubeola
Regulation
21 CFR 866.3520
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
4
Ingested recalls
0

Clearances, product code GRE

By decision year
4 clearances under product code GRE with a decision year between 1977 and 1988, 1977 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code GRE by decision year
YearClearances
19771
19821
19851
19881

Applicants with the most clearances

Product code GRE
Applicants holding the most 510(k) clearances under product code GRE
ApplicantClearances
Electro-Nucleonics Laboratories, Inc.1
Gull Laboratories, Inc.1
Idt, A Division of Whittaker M.A. Bioproducts1
Microbiological Assoc.1

Companies listing this code with FDA

Companies whose registered establishments list this code