CHIRON DIAGNOSTICS ACS: 180 FOLATE— 510(k) K991582

Name: FDA 510(k) clearance K991582
Creator: U.S. Food and Drug Administration
Published: 1999-06-30

Substantially Equivalent

Chiron Diagnostics Corp.

FDA 510(k) clearance K991582 for CHIRON DIAGNOSTICS ACS: 180 FOLATE, Substantially Equivalent on 1999-06-30. Applicant: Chiron Diagnostics Corp.. Device class: 2.

Clearance details

Applicant: Chiron Diagnostics Corp.
Product code: Code CGN
Device class: Class 2
Regulation: 21 CFR 862.1295
Advisory panel: Clinical Chemistry
Date received: 1999-05-07
Decision date: 1999-06-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Medfield, MA, US

Download summary PDF View on FDA.gov ↗

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