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FDA 510(k)

VISION SGOT (AST) - ADDIT. OF WHOLE BLOOD CLAIM

K-Number: K860465 · 1986-05-05

ApplicantAbbott Laboratories
Decision Date1986-05-05
Product CodeCIT
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

VISION SGOT (AST) - ADDIT. OF WHOLE BLOOD CLAIM is the device name listed in this FDA 510(k) record. The listed applicant is Abbott Laboratories. It received FDA 510(k) clearance on 1986-05-05 under 510(k) number K860465. The device is classified under product code CIT. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VISION SGOT (AST) - ADDIT. OF WHOLE BLOOD CLAIM?

VISION SGOT (AST) - ADDIT. OF WHOLE BLOOD CLAIM is a medical device that received FDA 510(k) clearance on 1986-05-05. The listed applicant is Abbott Laboratories. The 510(k) number is K860465.

When did VISION SGOT (AST) - ADDIT. OF WHOLE BLOOD CLAIM receive FDA 510(k) clearance?

VISION SGOT (AST) - ADDIT. OF WHOLE BLOOD CLAIM received FDA 510(k) clearance on 1986-05-05, under 510(k) number K860465.

Who is the listed applicant for VISION SGOT (AST) - ADDIT. OF WHOLE BLOOD CLAIM?

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

What is the FDA product code for VISION SGOT (AST) - ADDIT. OF WHOLE BLOOD CLAIM?

The FDA product code for VISION SGOT (AST) - ADDIT. OF WHOLE BLOOD CLAIM is CIT.

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Related Devices (Code: CIT)

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.

K093883AST/GOT 4+1 SL, AST/GOT 4+1 SL, ELICAL 2, ELITROL I, ELITROL II, MODEL ASSL-0250, ASSL-0455, CALI-0580, CONT-0080, CONT-Seppim S.A.S.K080485ASPARTATE AMINO TRANSFERASE (AST/SGOT) TEST SYSTEM, ASAT (GOT) FSDiasys Diagnostics Systems GmbHK071525ACTIVATED ASPARTATE AMINOTRANSFERASEAbbott LaboratoriesK071580AST/GOT (IFCC), PYRIDOXAL PHOSPHATE, ECAL, NORTROL AND ABTROLThermofisher Scientific OYK071211COBAS C 111 ANALYZERRoche DiagnosticsK060318HEPATIC ENZYMES ON ABX PENTRA 400 CLINICAL CHEMISTRY ANALYZERHoriba Abx

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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