Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

SOLARCARE ALANINE AMINOTRANSFERASE MICRO-PLATE ASSAY

K-Number: K941497 · 1994-05-24

ApplicantSolarcare, Inc.
Decision Date1994-05-24
Product CodeCKA
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

SOLARCARE ALANINE AMINOTRANSFERASE MICRO-PLATE ASSAY is the device name listed in this FDA 510(k) record. The listed applicant is Solarcare, Inc.. It received FDA 510(k) clearance on 1994-05-24 under 510(k) number K941497. The device is classified under product code CKA. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SOLARCARE ALANINE AMINOTRANSFERASE MICRO-PLATE ASSAY?

SOLARCARE ALANINE AMINOTRANSFERASE MICRO-PLATE ASSAY is a medical device that received FDA 510(k) clearance on 1994-05-24. The listed applicant is Solarcare, Inc.. The 510(k) number is K941497.

When did SOLARCARE ALANINE AMINOTRANSFERASE MICRO-PLATE ASSAY receive FDA 510(k) clearance?

SOLARCARE ALANINE AMINOTRANSFERASE MICRO-PLATE ASSAY received FDA 510(k) clearance on 1994-05-24, under 510(k) number K941497.

Who is the listed applicant for SOLARCARE ALANINE AMINOTRANSFERASE MICRO-PLATE ASSAY?

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

What is the FDA product code for SOLARCARE ALANINE AMINOTRANSFERASE MICRO-PLATE ASSAY?

The FDA product code for SOLARCARE ALANINE AMINOTRANSFERASE MICRO-PLATE ASSAY is CKA.

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_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Solarcare, Inc. 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.

K934775STC COCAINE METABOLITE EIAK944372STC DIAGNOSTIC AUTO-LYTE PROPOXYPHENE EIAK941496SOLARCARE TOTAL PROTEIN MICRO-PLATE ASSAYK934376STC DIAGNOSTICS AUTO-LYTE BARBITURATES EIAK933327HISTOFREEZER

Related Devices (Code: CKA)

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.

K120945HITACHI CLINICAL ANALYZER S TEST REAGENT CARTRIDGE ALT, HITACHI CLINICAL ANALYZER S TEST REAGENT CARTRIDGE ASTHitachi Chemical Diagnostics, Inc.K113382ACE ALT REAGENTAlfa WassermannK061020DIMENSION VISTA ALBUMIN, ALKALINE PHOSPHATASE, ASPARTATE AMINO TRANSFERASE, CARBAMAZEPINE & ALANINE AMINO TRANSFERASEDade Behring, Inc.K020487CARESIDE ALTCareside, Inc.K980028ALT (GPT) LIQUID STABLE 2 VIAL - INCORPORATING DYNAMIC STABILIZATION TECHNOLOGY - (DST)Trace America, Inc.K973869TRACE REAGENT LINE FOR THE COBAS MIRATrace America, Inc.

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.

↑