RECONDITIONED ASTRA (TM) 8— 510(k) K883298

Name: FDA 510(k) clearance K883298
Creator: U.S. Food and Drug Administration
Published: 1989-03-16

Substantially Equivalent

Associated Electro-Medical Services, Inc.

FDA 510(k) clearance K883298 for RECONDITIONED ASTRA (TM) 8, Substantially Equivalent on 1989-03-16. Applicant: Associated Electro-Medical Services, Inc.. Device class: 1.

Clearance details

Applicant: Associated Electro-Medical Services, Inc.
Product code: Code JJF
Device class: Class 1
Regulation: 21 CFR 862.2170
Advisory panel: Clinical Chemistry
Date received: 1988-08-04
Decision date: 1989-03-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Matthews, NC, US

Download summary PDF View on FDA.gov ↗

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