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FDA 510(k)

ALANINE AMINO TRANSFERASE (COLORIMETRIC METHOD)

K-Number: K883387 · 1988-10-13

ApplicantTech-Co, Inc.
Decision Date1988-10-13
Product CodeCKD
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ALANINE AMINO TRANSFERASE (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 1988-10-13 under 510(k) number K883387. The device is classified under product code CKD. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ALANINE AMINO TRANSFERASE (COLORIMETRIC METHOD)?

ALANINE AMINO TRANSFERASE (COLORIMETRIC METHOD) is a medical device that received FDA 510(k) clearance on 1988-10-13. The listed applicant is Tech-Co, Inc.. The 510(k) number is K883387.

When did ALANINE AMINO TRANSFERASE (COLORIMETRIC METHOD) receive FDA 510(k) clearance?

ALANINE AMINO TRANSFERASE (COLORIMETRIC METHOD) received FDA 510(k) clearance on 1988-10-13, under 510(k) number K883387.

Who is the listed applicant for ALANINE AMINO TRANSFERASE (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 ALANINE AMINO TRANSFERASE (COLORIMETRIC METHOD)?

The FDA product code for ALANINE AMINO TRANSFERASE (COLORIMETRIC METHOD) is CKD.

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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.

K921968IN VITRO DIAGNOSTIC REAGENT SET, INDIR. PREG. TESTK923376VISUAL HCG PREGNANCY TESTK920766T4 EIA BEAD ASSAYK920716DIRECT PREGNANCY TESTK902574POTASSIUM REAGENT SETK901561IRON/TOTAL IRON BINDING CAPACITY

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Related Devices (Code: CKD)

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.

K991834CHOLESTECH LDX ALANINE AMINOTRANSFERASE (ALT), MODEL 11-772Cholestech Corp.K941192ORTHO ALT MICROWELL TEST SYSTEMOrtho Diagnostic Systems, Inc.K896237COBAS READY ALT REAGENTRoche Diagnostic Systems, Inc.K884784VIRGO(R) MICROWELL ALT ASSAYElectro-Nucleonics, Inc.K864082REFLOTRON(R) ALT (GPT)Boehringer Mannheim Corp.K860485SGPT (ALT) REAGENT SET (COLORIMETRIC)Sterling 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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