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FDA 510(k)

ELVI SGOT & SGPT TRANSAMINASE

K-Number: K792410 · 1979-12-06

ApplicantVolu Sol Medical Industries
Decision Date1979-12-06
Product CodeCIS
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ELVI SGOT & SGPT TRANSAMINASE is the device name listed in this FDA 510(k) record. The listed applicant is Volu Sol Medical Industries. It received FDA 510(k) clearance on 1979-12-06 under 510(k) number K792410. 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 ELVI SGOT & SGPT TRANSAMINASE?

ELVI SGOT & SGPT TRANSAMINASE is a medical device that received FDA 510(k) clearance on 1979-12-06. The listed applicant is Volu Sol Medical Industries. The 510(k) number is K792410.

When did ELVI SGOT & SGPT TRANSAMINASE receive FDA 510(k) clearance?

ELVI SGOT & SGPT TRANSAMINASE received FDA 510(k) clearance on 1979-12-06, under 510(k) number K792410.

Who is the listed applicant for ELVI SGOT & SGPT TRANSAMINASE?

The FDA 510(k) record lists Volu Sol Medical Industries as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ELVI SGOT & SGPT TRANSAMINASE?

The FDA product code for ELVI SGOT & SGPT TRANSAMINASE is CIS.

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Other records listing Volu Sol Medical Industries 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.

K822128VOLU-SOL SINGLE DIFFERENTIAL STAINK822127VOLU-SOL ZENKERS FIXATIVEK822126VOLU-SOL CARNOY FLUIDK822129VOLU-SOL BOVINS FIXATIVEK822036VOLU-SOL DECALCIFERK822035VOLU-SOL GILLS EA

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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.

K032027CHOLESTECH LDX ASPARTATE AMINOTRANSFERASE (AST)Cholestech Corp.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 CO

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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