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

Antisera, All Types, Streptococcus Pneumoniae

21 CFR 866.3740 / Microbiology
FDA source (opens on fda.gov)

GWC is the FDA product code for Antisera, All Types, Streptococcus Pneumoniae, a class I device type, regulated under 21 CFR 866.3740. As of , FDA records hold 9 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
GWC
Device name
Antisera, All Types, Streptococcus Pneumoniae
Regulation
21 CFR 866.3740
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
9
Ingested recalls
0

Clearances, product code GWC

By decision year
9 clearances under product code GWC with a decision year between 1980 and 1989, 1984 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code GWC by decision year
YearClearances
19801
19821
19831
19842
19861
19871
19892

Applicants with the most clearances

Product code GWC
Applicants holding the most 510(k) clearances under product code GWC
ApplicantClearances
Armkel, LLC3
American Micro Scan1
BD Becton Dickinson Vacutainer Systems Preanalytic1
Lkb Instruments, Inc.1
Pharmacia, Inc.1
Ventrex Laboratories, Inc.1
Wellcome Diagnostics1

Companies listing this code with FDA

Companies whose registered establishments list this code