510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K962296Substantially Equivalent

Streptolex-Stat

Unipath, Ltd., Beverly MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K962296 is the FDA 510(k) clearance record for STREPTOLEX-STAT, a class I device, cleared for Unipath , Ltd. on under FDA product code GTZ (Antisera, All Groups, Streptococcus Spp.). FDA records list 73 510(k) clearances for Unipath , Ltd., from to . As of , FDA records show no recalls naming K962296.

Clearance record

Decision date
Received
(187 days to decision)
Product code
GTZ Antisera, All Groups, Streptococcus Spp.
Regulation
21 CFR 866.3740
Device class
Class I
Review panel
Microbiology
Applicant
Unipath , Ltd. 15 Oak St., Beverly MA
510(k) summary
Summary
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