510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K915852Substantially Equivalent

Accupace Group a Streptococcus Id Test

Hologic, Inc., San Diego CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K915852 is the FDA 510(k) clearance record for ACCUPACE GROUP A STREPTOCOCCUS ID TEST, a class I device, cleared for Gen-Probe, Inc. on under FDA product code MDK (Dna-Probe, Reagents, Streptococcal). FDA records list 189 510(k) clearances for Hologic, Inc., from to . As of , FDA records show no recalls naming K915852.

Clearance record

Decision date
Received
(97 days to decision)
Product code
MDK Dna-Probe, Reagents, Streptococcal
Regulation
21 CFR 866.3740
Device class
Class I
Review panel
Microbiology
Applicant
Gen-Probe, Inc. 9880 Campus Pt. Dr., San Diego CA
510(k) summary
Summary
Third party review
No

Clearances, product code MDK

Trailing 12 months

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

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