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FDA 510(k)

CHOLESTECH LDX ASPARTATE AMINOTRANSFERASE (AST)

K-Number: K032027 · 2003-09-05

ApplicantCholestech Corp.
Decision Date2003-09-05
Product CodeCIS
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

CHOLESTECH LDX ASPARTATE AMINOTRANSFERASE (AST) is the device name listed in this FDA 510(k) record. The listed applicant is Cholestech Corp.. It received FDA 510(k) clearance on 2003-09-05 under 510(k) number K032027. The device is classified under product code CIS. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CHOLESTECH LDX ASPARTATE AMINOTRANSFERASE (AST)?

CHOLESTECH LDX ASPARTATE AMINOTRANSFERASE (AST) is a medical device that received FDA 510(k) clearance on 2003-09-05. The listed applicant is Cholestech Corp.. The 510(k) number is K032027.

When did CHOLESTECH LDX ASPARTATE AMINOTRANSFERASE (AST) receive FDA 510(k) clearance?

CHOLESTECH LDX ASPARTATE AMINOTRANSFERASE (AST) received FDA 510(k) clearance on 2003-09-05, under 510(k) number K032027.

Who is the listed applicant for CHOLESTECH LDX ASPARTATE AMINOTRANSFERASE (AST)?

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 ASPARTATE AMINOTRANSFERASE (AST)?

The FDA product code for CHOLESTECH LDX ASPARTATE AMINOTRANSFERASE (AST) is CIS.

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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)K991834CHOLESTECH LDX ALANINE AMINOTRANSFERASE (ALT), MODEL 11-772K972012CHOLESTECH 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: CIS)

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.

K896238COBAS READY AST REAGENTRoche Diagnostic Systems, Inc.K854187IN-VITRO TEST DETERMINATION OF SGOT (AST)Clinical Data, Inc.K812872OPTIONAL TOTAL CA-MODULE FOR IL 504/508Instrumentation Laboratory COK792410ELVI SGOT & SGPT TRANSAMINASEVolu Sol Medical Industries

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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