APO-TEK LP(A)— 510(k) K970302

Substantially Equivalent

Perimmune, Inc.

FDA 510(k) clearance K970302 for APO-TEK LP(A), Substantially Equivalent on 1997-11-10. Applicant: Perimmune, Inc.. Device class: 2.

Clearance details

Applicant: Perimmune, Inc.
Product code: Code DFC
Device class: Class 2
Regulation: 21 CFR 866.5600
Advisory panel: Immunology
Date received: 1997-01-27
Decision date: 1997-11-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Rockville, MD, US

Download summary PDF View on FDA.gov ↗

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