510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K972129Substantially Equivalent

Chlamydiatrol Ag

Blackhawk Biosystems, Inc., San Ramon CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K972129 is the FDA 510(k) clearance record for CHLAMYDIATROL AG, a class I device, cleared for Blackhawk Biosystems, Inc. on under FDA product code MJZ (Kit, Direct Antigen, Positive Control). FDA records list 4 510(k) clearances for Blackhawk Biosystems, Inc., from to . As of , FDA records show no recalls naming K972129.

Clearance record

Decision date
Received
(67 days to decision)
Product code
MJZ Kit, Direct Antigen, Positive Control
Regulation
21 CFR 862.1660
Device class
Class I
Review panel
Clinical Chemistry
Applicant
Blackhawk Biosystems, Inc. 12945 Alcosta Blvd., San Ramon CA
510(k) summary
Summary
Third party review
No

Clearances, product code MJZ

Trailing 12 months

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

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