ANAEROBIC ACCU-CULSHURE(TM)— 510(k) K901645

Name: FDA 510(k) clearance K901645
Creator: U.S. Food and Drug Administration
Published: 1990-07-16

Substantially Equivalent

Medical Laboratory Automation Systems, Inc.

FDA 510(k) clearance K901645 for ANAEROBIC ACCU-CULSHURE(TM), Substantially Equivalent on 1990-07-16. Applicant: Medical Laboratory Automation Systems, Inc.. Device class: 1.

Clearance details

Applicant: Medical Laboratory Automation Systems, Inc.
Product code: Code JTX
Device class: Class 1
Regulation: 21 CFR 866.2900
Advisory panel: Microbiology
Date received: 1990-04-09
Decision date: 1990-07-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Pleasantville, NY, US

Download summary PDF View on FDA.gov ↗

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