510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K974572Substantially Equivalent

Gen-Probe Accuprobe Group B Streptococcus Culture Identification Test 2820

Chugai Pharmaceuticals Co., Ltd., San Diego CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K974572 is the FDA 510(k) clearance record for GEN-PROBE ACCUPROBE GROUP B STREPTOCOCCUS CULTURE IDENTIFICATION TEST 2820, a class I device, cleared for Chugai Pharmaceuticals Co., Ltd. on under FDA product code MDK (Dna-Probe, Reagents, Streptococcal). FDA records list one 510(k) clearance for Chugai Pharmaceuticals Co., Ltd. As of , FDA records show 2 recalls naming K974572.

Clearance record

Decision date
Received
(293 days to decision)
Product code
MDK Dna-Probe, Reagents, Streptococcal
Regulation
21 CFR 866.3740
Device class
Class I
Review panel
Microbiology
Applicant
Chugai Pharmaceuticals Co., Ltd. 10210 Genetic Center 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