510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K842827Substantially Equivalent

Streptex Direct a Zl14

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

K842827 is the FDA 510(k) clearance record for STREPTEX DIRECT A ZL14, 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 K842827.

Clearance record

Decision date
Received
(27 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 803 N. Front St. Suite 3, Mchenry IL
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