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FDA 510(k)

EASY-TEST LACTIC ACID (LA)

K-Number: K880787 · 1988-03-15

ApplicantDiagnostic Systems
Decision Date1988-03-15
Product CodeKHP
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

EASY-TEST LACTIC ACID (LA) is the device name listed in this FDA 510(k) record. The listed applicant is Diagnostic Systems. It received FDA 510(k) clearance on 1988-03-15 under 510(k) number K880787. The device is classified under product code KHP. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EASY-TEST LACTIC ACID (LA)?

EASY-TEST LACTIC ACID (LA) is a medical device that received FDA 510(k) clearance on 1988-03-15. The listed applicant is Diagnostic Systems. The 510(k) number is K880787.

When did EASY-TEST LACTIC ACID (LA) receive FDA 510(k) clearance?

EASY-TEST LACTIC ACID (LA) received FDA 510(k) clearance on 1988-03-15, under 510(k) number K880787.

Who is the listed applicant for EASY-TEST LACTIC ACID (LA)?

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

What is the FDA product code for EASY-TEST LACTIC ACID (LA)?

The FDA product code for EASY-TEST LACTIC ACID (LA) is KHP.

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 Diagnostic Systems 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.

K905146OLYMPUS URINE PHK893691EMDS CREATINE KINASE ITEM NIMBER 65411K893692EMDS ASPARTATE AMINOTRANSFERASE ITEM NUMBER 65405K893966HDL PRECIPITATING REAGENTK884993VISUAL BLOOD GLUCOSE TEST SYSTEMK881116EASY-TEST EMIT(R) LIDOCAINE LIDO ITEM NO. 16641

View all 14 devices →

Related Devices (Code: KHP)

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.

K130113PICCOLO LACTATE TEST SYSTEMAbaxis, Inc.K113216RAPIDPOINT 500 BLOOD GAS ANALYERSiemens Healthcare DiagnosticsK112955NOVA STATSTRIP LACTATE HOSPITAL METER SYSTEMNova Biomedical CorporationK112430I-STAT LACTATE TEST/I-SAT CG4+CARTRIDGEAbbott Pont of Care, Inc.K100602NOVA STATSTRIP LACTATE HOSPITAL METER, NOVA STATSTRIP LACTATE TEST STRIPSNova Biomedical Corp.K093297EPOC BGEM, EPOC READER, EPOC HOST, EPOC CARE-FILL CAPILLARY TUBEEpocal, 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.

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