510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K841376Substantially Equivalent

Wellcogen S. Pneumoniae

Wellcome Diagnostics, Walker MI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K841376 is the FDA 510(k) clearance record for WELLCOGEN S. PNEUMONIAE, a class I device, cleared for Wellcome Diagnostics on under FDA product code GWC (Antisera, All Types, Streptococcus Pneumoniae). FDA records list 28 510(k) clearances for Wellcome Diagnostics, from to . As of , FDA records show no recalls naming K841376.

Clearance record

Decision date
Received
(29 days to decision)
Product code
GWC Antisera, All Types, Streptococcus Pneumoniae
Regulation
21 CFR 866.3740
Device class
Class I
Review panel
Microbiology
Applicant
Wellcome Diagnostics 4221 Richmond Rd., NW, Walker MI
Third party review
No

Clearances, product code GWC

Trailing 12 months

FDA records hold no clearances under product code GWC in the trailing twelve months.

FDA records show no clearances under product code GWC in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code GWC, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260