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FDA 510(k)

CHOLESTECH LDX ALANINE AMINOTRANSFERASE (ALT), MODEL 11-772

K-Number: K991834 · 1999-09-09

ApplicantCholestech Corp.
Decision Date1999-09-09
Product CodeCKD
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

CHOLESTECH LDX ALANINE AMINOTRANSFERASE (ALT), MODEL 11-772 is the device name listed in this FDA 510(k) record. The listed applicant is Cholestech Corp.. It received FDA 510(k) clearance on 1999-09-09 under 510(k) number K991834. 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 CHOLESTECH LDX ALANINE AMINOTRANSFERASE (ALT), MODEL 11-772?

CHOLESTECH LDX ALANINE AMINOTRANSFERASE (ALT), MODEL 11-772 is a medical device that received FDA 510(k) clearance on 1999-09-09. The listed applicant is Cholestech Corp.. The 510(k) number is K991834.

When did CHOLESTECH LDX ALANINE AMINOTRANSFERASE (ALT), MODEL 11-772 receive FDA 510(k) clearance?

CHOLESTECH LDX ALANINE AMINOTRANSFERASE (ALT), MODEL 11-772 received FDA 510(k) clearance on 1999-09-09, under 510(k) number K991834.

Who is the listed applicant for CHOLESTECH LDX ALANINE AMINOTRANSFERASE (ALT), MODEL 11-772?

The FDA 510(k) record lists Cholestech Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CHOLESTECH LDX ALANINE AMINOTRANSFERASE (ALT), MODEL 11-772?

The FDA product code for CHOLESTECH LDX ALANINE AMINOTRANSFERASE (ALT), MODEL 11-772 is CKD.

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Other records listing Cholestech Corp. 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.

K040579CHOLETECH LDX HIGH-SENSITIVITY C-REACTIVE PROTEIN (HS-CRP)K032027CHOLESTECH LDX ASPARTATE AMINOTRANSFERASE (AST)K972012CHOLESTECH BUN/CREATININE TEST SYSTEMK954778CHOLESTECH LDX SYSTEMK946067TOTAL CHOLESTEROL, HDL CHOLESTEROL, TRIGLYCERIDES AND GLUCOSE PANELK946066TOTAL CHOLESTEROL, HDL CHOLESTEROL AND GLUCOSE PANEL

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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.

K941192ORTHO ALT MICROWELL TEST SYSTEMOrtho Diagnostic Systems, Inc.K896237COBAS READY ALT REAGENTRoche Diagnostic Systems, Inc.K884784VIRGO(R) MICROWELL ALT ASSAYElectro-Nucleonics, Inc.K883387ALANINE AMINO TRANSFERASE (COLORIMETRIC METHOD)Tech-Co, 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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