IMMULITE PSA CONTROL MODULE, MODEL LPSCM— 510(k) K982637

Name: FDA 510(k) clearance K982637
Creator: U.S. Food and Drug Administration
Published: 1998-08-12

Substantially Equivalent

Diagnostic Products Corp.

FDA 510(k) clearance K982637 for IMMULITE PSA CONTROL MODULE, MODEL LPSCM, Substantially Equivalent on 1998-08-12. Applicant: Diagnostic Products Corp.. Device class: 1.

Clearance details

Applicant: Diagnostic Products Corp.
Product code: Code JJY
Device class: Class 1
Regulation: 21 CFR 862.1660
Advisory panel: Clinical Chemistry
Date received: 1998-07-29
Decision date: 1998-08-12
Decision: Substantially Equivalent
Clearance type: Special
Location: Los Angeles, CA, US

Download summary PDF View on FDA.gov ↗

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