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FDA 510(k)

N-ASSAY TIA FIBRINOGEN TEST KIT

K-Number: K965113 · 1997-04-16

ApplicantCrestat Diagnostics, Inc.
Decision Date1997-04-16
Product CodeKQJ
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

N-ASSAY TIA FIBRINOGEN 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 1997-04-16 under 510(k) number K965113. The device is classified under product code KQJ. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the N-ASSAY TIA FIBRINOGEN TEST KIT?

N-ASSAY TIA FIBRINOGEN TEST KIT is a medical device that received FDA 510(k) clearance on 1997-04-16. The listed applicant is Crestat Diagnostics, Inc.. The 510(k) number is K965113.

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

N-ASSAY TIA FIBRINOGEN TEST KIT received FDA 510(k) clearance on 1997-04-16, under 510(k) number K965113.

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

The FDA product code for N-ASSAY TIA FIBRINOGEN TEST KIT is KQJ.

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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: KQJ)

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.

K251968HemosIL Fibrinogen-C; HemosIL Fibrinogen-C XLInstrumentation Laboratory (IL) Co.K073367HEMOSIL FIBRINOGEN-CInstrumentation Laboratory COK050928DADE THROMBIN REAGENTDade Behring, Inc.K971858SIGMA DIAGNOSTICS FIBRINOGEN KIT (886A/887A)Sigma Diagnostics, Inc.K970189FIF TMPanbio, Inc.K934326MULTIFIBREN UBehring Diagnostics, 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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