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FDA 510(k)

N-ASSAY TIA APO B TEST KIT

K-Number: K964296 · 1997-08-01

ApplicantCrestat Diagnostics, Inc.
Decision Date1997-08-01
Product CodeDER
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

N-ASSAY TIA APO B TEST KIT is the device name listed in this FDA 510(k) record. The listed applicant is Crestat Diagnostics, Inc.. It received FDA 510(k) clearance on 1997-08-01 under 510(k) number K964296. The device is classified under product code DER. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the N-ASSAY TIA APO B TEST KIT?

N-ASSAY TIA APO B TEST KIT is a medical device that received FDA 510(k) clearance on 1997-08-01. The listed applicant is Crestat Diagnostics, Inc.. The 510(k) number is K964296.

When did N-ASSAY TIA APO B TEST KIT receive FDA 510(k) clearance?

N-ASSAY TIA APO B TEST KIT received FDA 510(k) clearance on 1997-08-01, under 510(k) number K964296.

Who is the listed applicant for N-ASSAY TIA APO B TEST KIT?

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

What is the FDA product code for N-ASSAY TIA APO B TEST KIT?

The FDA product code for N-ASSAY TIA APO B TEST KIT is DER.

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Other records listing Crestat Diagnostics, Inc. 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.

K980883N-ASSAY GLU-ULK981276N-ASSAY L D-BILK981289N-ASSAY L T-BILK980900N-ASSAY CPK-LK980902N-ASSAY L AST/GOTK971985N-ASSAY TIA PLASMINOGEN TEST KIT

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Related Devices (Code: DER)

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.

K013249TINA-QUANT APOLIPOPROTEIN VER.2Roche Diagnostics Corp.K000921BAYER ADVIA IMS SYSTEM; 200 + 3Bayer Corp.K993354K-ASSAY APO BKamiya Biomedical Co.K993345K-ASSAY APO AIKamiya Biomedical Co.K990594INTEGRA REAGENT CASSETTE FOR APOLIPOPROTEIN A-1Roche Diagnostics Corp.K983289APOLIPOPROTEIN A1Abbott Laboratories

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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