510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K842828Substantially Equivalent

Streptex Zl01

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

K842828 is the FDA 510(k) clearance record for STREPTEX ZL01, a class I device, cleared for Wellcome Diagnostics on under FDA product code JTO (Discs, Strips And Reagents, Microorganism Differentiation). FDA records list 28 510(k) clearances for Wellcome Diagnostics, from to . As of , FDA records show 2 recalls naming K842828.

Clearance record

Decision date
Received
(26 days to decision)
Product code
JTO Discs, Strips And Reagents, Microorganism Differentiation
Regulation
21 CFR 866.2660
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 JTO

Trailing 12 months

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

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