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FDA 510(k)

CHIRON DIAGNOSTICS ACS:180TU P

K-Number: K970539 · 1997-03-24

ApplicantChiron Diagnostics Corp.
Decision Date1997-03-24
Product CodeKHQ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

CHIRON DIAGNOSTICS ACS:180TU P is the device name listed in this FDA 510(k) record. The listed applicant is Chiron Diagnostics Corp.. It received FDA 510(k) clearance on 1997-03-24 under 510(k) number K970539. The device is classified under product code KHQ. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CHIRON DIAGNOSTICS ACS:180TU P?

CHIRON DIAGNOSTICS ACS:180TU P is a medical device that received FDA 510(k) clearance on 1997-03-24. The listed applicant is Chiron Diagnostics Corp.. The 510(k) number is K970539.

When did CHIRON DIAGNOSTICS ACS:180TU P receive FDA 510(k) clearance?

CHIRON DIAGNOSTICS ACS:180TU P received FDA 510(k) clearance on 1997-03-24, under 510(k) number K970539.

Who is the listed applicant for CHIRON DIAGNOSTICS ACS:180TU P?

The FDA 510(k) record lists Chiron Diagnostics Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CHIRON DIAGNOSTICS ACS:180TU P?

The FDA product code for CHIRON DIAGNOSTICS ACS:180TU P is KHQ.

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Other records listing Chiron Diagnostics Corp. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K992157CHIRON DIAGNOSTICS ACS: 180 FERRITIN ASSAYK991582CHIRON DIAGNOSTICS ACS: 180 FOLATEK991692CHIRON DIAGNOSTICS ACS: 180 FT3K982680CHIRON DIAGNOSTICS CORPORATION ACS: CENTAUR BR IMMUNOASSAYK981478ACS:CENTAUR CEAK981839ACS:CENTAUR PSA2 IMMUNOASSAY

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Related Devices (Code: KHQ)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K981375ACE T UPTAKE REAGENT TU CALIBRATORSSchiapparelli Biosystems, Inc.K980088T-UPTAKE MICROPLATE EIAMonobindK964308VITROS IMMUNODIAGNOSTICS PRODUCTS T3 UPTAKE REAGENT PACK (GEM.1025) AND T3 UPTAKE CALIBRATORS (GEM.C025)Johnson & Johnson Clinical Diagnostics, Inc.K961488ELECSYS T-UPTAKE ASSAYBoehringer Mannheim Corp.K954807CEDIA T UPTAKE ASSAYBoehringer Mannheim Corp.K951586T-UPTAKE EIA TESTDiagnostic Reagents, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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