510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K833738Substantially Equivalent

Leap Strep Test Kit

Cooper Biomedical, Inc., Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K833738 is the FDA 510(k) clearance record for LEAP STREP TEST KIT, a class I device, cleared for Cooper Biomedical, Inc. on under FDA product code GTP (Exoenzymes, Multiple, Streptococcal). FDA records list 19 510(k) clearances for Cooper Biomedical, Inc., from to . As of , FDA records show no recalls naming K833738.

Clearance record

Decision date
Received
(63 days to decision)
Product code
GTP Exoenzymes, Multiple, Streptococcal
Regulation
21 CFR 866.3720
Device class
Class I
Review panel
Microbiology
Applicant
Cooper Biomedical, Inc. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code GTP

Trailing 12 months

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

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