510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K170481Substantially Equivalent

Strep B Carrot Broth Kit

Hardy Diagnostics, Santa Maria CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K170481 is the FDA 510(k) clearance record for Strep B Carrot Broth Kit, a class I device, cleared for Hardy Diagnostics on under FDA product code PQZ (Gbs Culture Media, Selective And Differential). FDA's definition for product code PQZ reads: "Culture Medium for GBS Detection". FDA records list 109 510(k) clearances for Hardy Diagnostics, from to . As of , FDA records show no recalls naming K170481.

Clearance record

Decision date
Received
(89 days to decision)
Product code
PQZ Gbs Culture Media, Selective And Differential
Regulation
21 CFR 866.2360
Device class
Class I
Review panel
Microbiology
Applicant
Hardy Diagnostics 1430 W. Mccoy Ln., Santa Maria CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code PQZ

Trailing 12 months

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

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