FDA 510(k)

VISION SGOT (AST)

K-Number: K854982 · 1986-01-14

Decision Date1986-01-14

Product CodeCIT

Advisory CommitteeCH

DecisionSubstantially Equivalent

Device Summary

VISION SGOT (AST) is the device name listed in this FDA 510(k) record. The listed applicant is Abbott Laboratories. It received FDA 510(k) clearance on 1986-01-14 under 510(k) number K854982. 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)?

VISION SGOT (AST) is a medical device that received FDA 510(k) clearance on 1986-01-14. The listed applicant is Abbott Laboratories. The 510(k) number is K854982.

When did VISION SGOT (AST) receive FDA 510(k) clearance?

VISION SGOT (AST) received FDA 510(k) clearance on 1986-01-14, under 510(k) number K854982.

Who is the listed applicant for VISION SGOT (AST)?

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)?

The FDA product code for VISION SGOT (AST) is CIT.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITING NCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITING NCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED NCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Abbott Laboratories as applicant

K262156Anti-HCV Next K252424Anti-HCV Next K243500ARCHITECT iGentamicin K243168Alinity i Rubella IgG K243283Alinity h-series System K233932Alinity i Toxo IgM

View all 876 devices →

Related Devices (Code: CIT)

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 GmbH K071525ACTIVATED ASPARTATE AMINOTRANSFERASEAbbott Laboratories K071580AST/GOT (IFCC), PYRIDOXAL PHOSPHATE, ECAL, NORTROL AND ABTROLThermofisher Scientific OY K071211COBAS C 111 ANALYZERRoche Diagnostics K060318HEPATIC 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.