510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K864206Substantially Equivalent

Reveal Colour Strep a Zl16

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

K864206 is the FDA 510(k) clearance record for REVEAL COLOUR STREP A ZL16, a class I device, cleared for Wellcome Diagnostics on under FDA product code GTZ (Antisera, All Groups, Streptococcus Spp.). FDA records list 28 510(k) clearances for Wellcome Diagnostics, from to . As of , FDA records show no recalls naming K864206.

Clearance record

Decision date
Received
(78 days to decision)
Product code
GTZ Antisera, All Groups, Streptococcus Spp.
Regulation
21 CFR 866.3740
Device class
Class I
Review panel
Microbiology
Applicant
Wellcome Diagnostics 3030 Cornwallis Rd., Research Triangle Pk NC
Third party review
No

Clearances, product code GTZ

Trailing 12 months

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

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