CHIRON DIAGNOSTICS ACS:180TU P— 510(k) K970539

Name: FDA 510(k) clearance K970539
Creator: U.S. Food and Drug Administration
Published: 1997-03-24

Substantially Equivalent

Chiron Diagnostics Corp.

FDA 510(k) clearance K970539 for CHIRON DIAGNOSTICS ACS:180TU P, Substantially Equivalent on 1997-03-24. Applicant: Chiron Diagnostics Corp.. Device class: 2.

Clearance details

Applicant: Chiron Diagnostics Corp.
Product code: Code KHQ
Device class: Class 2
Regulation: 21 CFR 862.1715
Advisory panel: Clinical Chemistry
Date received: 1997-02-12
Decision date: 1997-03-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Medfield, MA, US

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K961488 — ELECSYS T-UPTAKE ASSAY1996-06-12
K954807 — CEDIA T UPTAKE ASSAY1995-12-21

More clearances from Chiron Diagnostics Corp.

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K992157 — CHIRON DIAGNOSTICS ACS: 180 FERRITIN ASSAY1999-08-05
K991582 — CHIRON DIAGNOSTICS ACS: 180 FOLATE1999-06-30
K991692 — CHIRON DIAGNOSTICS ACS: 180 FT31999-06-18
K982680 — CHIRON DIAGNOSTICS CORPORATION ACS: CENTAUR BR IMMUNOASSAY1998-10-15
K981478 — ACS:CENTAUR CEA1998-08-12

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