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FDA 510(k)

N-ASSAY TIA C1-INACTIVATOR TEST KIT

K-Number: K965024 · 1997-07-14

ApplicantCrestat Diagnostics, Inc.
Decision Date1997-07-14
Product CodeDBA
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

N-ASSAY TIA C1-INACTIVATOR 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 1997-07-14 under 510(k) number K965024. The device is classified under product code DBA. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the N-ASSAY TIA C1-INACTIVATOR TEST KIT?

N-ASSAY TIA C1-INACTIVATOR TEST KIT is a medical device that received FDA 510(k) clearance on 1997-07-14. The listed applicant is Crestat Diagnostics, Inc.. The 510(k) number is K965024.

When did N-ASSAY TIA C1-INACTIVATOR TEST KIT receive FDA 510(k) clearance?

N-ASSAY TIA C1-INACTIVATOR TEST KIT received FDA 510(k) clearance on 1997-07-14, under 510(k) number K965024.

Who is the listed applicant for N-ASSAY TIA C1-INACTIVATOR 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 C1-INACTIVATOR TEST KIT?

The FDA product code for N-ASSAY TIA C1-INACTIVATOR TEST KIT is DBA.

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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: DBA)

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.

K122304HUMAN C1 INACTIVATOR KIT FOR USE ON SPAPLUSThe Binding Site Group , Ltd.K072965DIMENSION VISTA C1 IN; FLEX REAGENT CARTRIDGE, CAL, CONDade Behring, Inc.K011780K-ASSAY C1-INAKamiya Biomedical Co.K003747C1-INHIBITOR MICROTITER ASSAY DEVICEBaxter Healthcare CorpK960257N ANTISERUM TO C1 INHIBITORBehring Diagnostics, Inc.K951967HUMAN C1 INACTIVATOR OR C-1 ESTERASE INHIBITOR RADIAL IMMUNODIFFUSION KITKent Laboratories, 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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