GEN-PROBE ACCUPROBE GROUP B STREPTOCOCCUS CULTURE IDENTIFICATION TEST 2820— 510(k) K974572

Name: FDA 510(k) clearance K974572
Creator: U.S. Food and Drug Administration
Published: 1998-09-24

Substantially Equivalent

Chugai Pharmaceuticals Co., Ltd.

FDA 510(k) clearance K974572 for GEN-PROBE ACCUPROBE GROUP B STREPTOCOCCUS CULTURE IDENTIFICATION TEST 2820, Substantially Equivalent on 1998-09-24. Applicant: Chugai Pharmaceuticals Co., Ltd.. Device class: 1.

Clearance details

Applicant: Chugai Pharmaceuticals Co., Ltd.
Product code: Code MDK
Device class: Class 1
Regulation: 21 CFR 866.3740
Advisory panel: Microbiology
Date received: 1997-12-05
Decision date: 1998-09-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Diego, CA, US

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