SPECTROLYSE ANTITHROMBIN III (ANTI-XA)— 510(k) K960871

Name: FDA 510(k) clearance K960871
Creator: U.S. Food and Drug Administration
Published: 1996-08-14

Substantially Equivalent

Medical Diagnostic Technologies, Inc.

FDA 510(k) clearance K960871 for SPECTROLYSE ANTITHROMBIN III (ANTI-XA), Substantially Equivalent on 1996-08-14. Applicant: Medical Diagnostic Technologies, Inc.. Device class: 2.

Clearance details

Applicant: Medical Diagnostic Technologies, Inc.
Product code: Code JBQ
Device class: Class 2
Regulation: 21 CFR 864.7060
Advisory panel: Hematology
Date received: 1996-03-04
Decision date: 1996-08-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Ventura, CA, US

Download summary PDF View on FDA.gov ↗

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