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

Antigen, Ha (Including Ha Control), Rubella

21 CFR 866.3510 / Microbiology
FDA source (opens on fda.gov)

GOL is the FDA product code for Antigen, Ha (Including Ha Control), Rubella, a class II device type, regulated under 21 CFR 866.3510. As of , FDA records hold 21 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
GOL
Device name
Antigen, Ha (Including Ha Control), Rubella
Regulation
21 CFR 866.3510
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
21
Ingested recalls
0

Clearances, product code GOL

By decision year
21 clearances under product code GOL with a decision year between 1976 and 1984, 1980 the highest year at 9.
Show the numbers
510(k) clearances under FDA product code GOL by decision year
YearClearances
19761
19774
19794
19809
19811
19842

Applicants with the most clearances

Product code GOL
Applicants holding the most 510(k) clearances under product code GOL
ApplicantClearances
Abbott Medical3
Flow Laboratories, Inc.3
Calbiochem-Behring Corp.2
Cordis US Corp.2
Intl. Diagnostic Technology2
Litton Bionetics2
BD Becton Dickinson Vacutainer Systems Preanalytic1
Beckman Instruments, Inc.1
Behring Diagnostics, Inc.1
Clinical Assays, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code

No registered establishment in MDM’s records lists product code GOL.