PACE-4-AUTOMATIC RIA GAMMA-COUTER— 510(k) K802578

Name: FDA 510(k) clearance K802578
Creator: U.S. Food and Drug Administration
Published: 1980-12-18

Substantially Equivalent

Philips Medical Systems (Cleveland), Inc.

FDA 510(k) clearance K802578 for PACE-4-AUTOMATIC RIA GAMMA-COUTER, Substantially Equivalent on 1980-12-18. Applicant: Philips Medical Systems (Cleveland), Inc.. Device class: 1.

Clearance details

Applicant: Philips Medical Systems (Cleveland), Inc.
Product code: Code JJJ
Device class: Class 1
Regulation: 21 CFR 862.2320
Advisory panel: Clinical Chemistry
Date received: 1980-10-20
Decision date: 1980-12-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walker, MI, US

Download summary PDF View on FDA.gov ↗

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