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FDA 510(k)

EASY-TEST EMIT(R) LIDOCAINE LIDO ITEM NO. 16641

K-Number: K881116 · 1988-06-20

ApplicantDiagnostic Systems
Decision Date1988-06-20
Product CodeKLR
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

EASY-TEST EMIT(R) LIDOCAINE LIDO ITEM NO. 16641 is the device name listed in this FDA 510(k) record. The listed applicant is Diagnostic Systems. It received FDA 510(k) clearance on 1988-06-20 under 510(k) number K881116. The device is classified under product code KLR. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EASY-TEST EMIT(R) LIDOCAINE LIDO ITEM NO. 16641?

EASY-TEST EMIT(R) LIDOCAINE LIDO ITEM NO. 16641 is a medical device that received FDA 510(k) clearance on 1988-06-20. The listed applicant is Diagnostic Systems. The 510(k) number is K881116.

When did EASY-TEST EMIT(R) LIDOCAINE LIDO ITEM NO. 16641 receive FDA 510(k) clearance?

EASY-TEST EMIT(R) LIDOCAINE LIDO ITEM NO. 16641 received FDA 510(k) clearance on 1988-06-20, under 510(k) number K881116.

Who is the listed applicant for EASY-TEST EMIT(R) LIDOCAINE LIDO ITEM NO. 16641?

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 EMIT(R) LIDOCAINE LIDO ITEM NO. 16641?

The FDA product code for EASY-TEST EMIT(R) LIDOCAINE LIDO ITEM NO. 16641 is KLR.

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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 SYSTEMK880787EASY-TEST LACTIC ACID (LA)

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Related Devices (Code: KLR)

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.

K090282QMS LIDOCAINEThermo Fisher Scientific, Inc.K033809DIMENSION LIDOCAINE (LIDO) FLEX REAGENT CARTRIDGE METHOD, DIMENSION DRUG CALIBRATOR II, MODELS DF113. DC49DDade Behring, Inc.K032334ROCHE ONLINE TDM LIDOCAINERoche Diagnostics Corp.K973102LIDOCAINE EIA ASSAYDiagnostic Reagents, Inc.K853010COBAS REAGENT FOR LIDOCAINE & CALIBRATORSRoche Diagnostic Systems, Inc.K843184STRATUS LIDOCAINE FLUOROMETRIC ENZYMEAmerican Dade

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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