ATI DISPOSABLE BIOLOGICAL TEST PACK— 510(k) K855120

Name: FDA 510(k) clearance K855120
Creator: U.S. Food and Drug Administration
Published: 1986-06-18

Substantially Equivalent

Parke-Davis Co.

FDA 510(k) clearance K855120 for ATI DISPOSABLE BIOLOGICAL TEST PACK, Substantially Equivalent on 1986-06-18. Applicant: Parke-Davis Co.. Device class: 2.

Clearance details

Applicant: Parke-Davis Co.
Product code: Code FRC
Device class: Class 2
Regulation: 21 CFR 880.2800
Advisory panel: General Hospital
Date received: 1985-12-23
Decision date: 1986-06-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Rochester, MI, US

Download summary PDF View on FDA.gov ↗

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