510(K) CLEARANCES 49 ▼18RECALLS POSTED 23 ▼3CLASS I 1 ▼1PMA DECISIONS 37 ▼3WEEK ENDING / FDA DATA AS OF
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K894711Substantially Equivalent

Accuprobe Group B Streptococcus Culture Confirma.

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

K894711 is the FDA 510(k) clearance record for ACCUPROBE GROUP B STREPTOCOCCUS CULTURE CONFIRMA., a class I device, cleared for Gen-Probe, Inc. on under FDA product code GTZ (Antisera, All Groups, Streptococcus Spp.). FDA records list 189 510(k) clearances for Hologic, Inc., from to . As of , FDA records show no recalls naming K894711.

Clearance record

Decision date
Received
(111 days to decision)
Product code
GTZ Antisera, All Groups, Streptococcus Spp.
Regulation
21 CFR 866.3740
Device class
Class I
Review panel
Microbiology
Applicant
Gen-Probe, Inc. 9880 Campus Pt. Dr., San Diego CA
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 November 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code GTZ, trailing twelve months
MonthClearances
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260
November 20260