FDA 510(k)

AST/GOT REAGENT SET UV RATE

K-Number: K842521 · 1984-08-12

Decision Date1984-08-12

Product CodeCIT

Advisory CommitteeCH

DecisionSubstantially Equivalent

Device Summary

AST/GOT REAGENT SET UV RATE is the device name listed in this FDA 510(k) record. The listed applicant is Sterling Biochemical, Inc.. It received FDA 510(k) clearance on 1984-08-12 under 510(k) number K842521. 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 AST/GOT REAGENT SET UV RATE?

AST/GOT REAGENT SET UV RATE is a medical device that received FDA 510(k) clearance on 1984-08-12. The listed applicant is Sterling Biochemical, Inc.. The 510(k) number is K842521.

When did AST/GOT REAGENT SET UV RATE receive FDA 510(k) clearance?

AST/GOT REAGENT SET UV RATE received FDA 510(k) clearance on 1984-08-12, under 510(k) number K842521.

Who is the listed applicant for AST/GOT REAGENT SET UV RATE?

The FDA 510(k) record lists Sterling Biochemical, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AST/GOT REAGENT SET UV RATE?

The FDA product code for AST/GOT REAGENT SET UV RATE 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 Sterling Biochemical, Inc. as applicant

K844998GLUCOSE(HEXOKINASE) REAGENT SET K844251ALT/GPT REAGENT SET K843332ALKALINE PHOSPHATASE REAGENT SET K840064UREA NITROGEN REAGENT SET K834084HYDROXYBUTYRATE DEHYDROGENASE REAGENT K834045URIC ACID REAGENT SET

View all 15 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.