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FDA 510(k)

ASPARTATE AMINOTRANSFERASE (COLORIMETRIC METHOD)

K-Number: K881173 · 1988-06-07

ApplicantTech-Co, Inc.
Decision Date1988-06-07
Product CodeCIQ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ASPARTATE AMINOTRANSFERASE (COLORIMETRIC METHOD) is the device name listed in this FDA 510(k) record. The listed applicant is Tech-Co, Inc.. It received FDA 510(k) clearance on 1988-06-07 under 510(k) number K881173. The device is classified under product code CIQ. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ASPARTATE AMINOTRANSFERASE (COLORIMETRIC METHOD)?

ASPARTATE AMINOTRANSFERASE (COLORIMETRIC METHOD) is a medical device that received FDA 510(k) clearance on 1988-06-07. The listed applicant is Tech-Co, Inc.. The 510(k) number is K881173.

When did ASPARTATE AMINOTRANSFERASE (COLORIMETRIC METHOD) receive FDA 510(k) clearance?

ASPARTATE AMINOTRANSFERASE (COLORIMETRIC METHOD) received FDA 510(k) clearance on 1988-06-07, under 510(k) number K881173.

Who is the listed applicant for ASPARTATE AMINOTRANSFERASE (COLORIMETRIC METHOD)?

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

What is the FDA product code for ASPARTATE AMINOTRANSFERASE (COLORIMETRIC METHOD)?

The FDA product code for ASPARTATE AMINOTRANSFERASE (COLORIMETRIC METHOD) is CIQ.

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Other records listing Tech-Co, 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.

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Related Devices (Code: CIQ)

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.

K860216SGOT (AST) REAGENT SETSterling Diagnostics, Inc.K855189GLUTAMIC OXALOACETIC TRANSAMINASE REAGENT SETTechnostics Intl.K844322SGOT REAGENT SETLivonia Diagnostics, Inc.K841065SGOT REAGENT SETMedical Specialties, Inc.K821209SGOT REAGENT SETOmega Medical ElectronicsK820466SGOT REAGENT SETAnco Medical Reagents & Assoc.

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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