510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K854851Substantially Equivalent

Wellcogen N. Meningitidis B/e. Coli K1 Zl24

Wellcome Diagnostics, Research Triangle Pk NC / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K854851 is the FDA 510(k) clearance record for WELLCOGEN N. MENINGITIDIS B/E. COLI K1 ZL24, a class II device, cleared for Wellcome Diagnostics on under FDA product code GTJ (Antisera, All Groups, N. Meningitidis). FDA records list 28 510(k) clearances for Wellcome Diagnostics, from to . As of , FDA records show no recalls naming K854851.

Clearance record

Decision date
Received
(61 days to decision)
Product code
GTJ Antisera, All Groups, N. Meningitidis
Regulation
21 CFR 866.3390
Device class
Class II
Review panel
Microbiology
Applicant
Wellcome Diagnostics 3030 Cornwallis Rd., Research Triangle Pk NC
Third party review
No

Clearances, product code GTJ

Trailing 12 months

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

FDA records show no clearances under product code GTJ in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code GTJ, 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