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FDA 510(k)

STRATUS LIDOCAINE FLUOROMETRIC ENZYME

K-Number: K843184 · 1984-09-26

ApplicantAmerican Dade
Decision Date1984-09-26
Product CodeKLR
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

STRATUS LIDOCAINE FLUOROMETRIC ENZYME is the device name listed in this FDA 510(k) record. The listed applicant is American Dade. It received FDA 510(k) clearance on 1984-09-26 under 510(k) number K843184. 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 STRATUS LIDOCAINE FLUOROMETRIC ENZYME?

STRATUS LIDOCAINE FLUOROMETRIC ENZYME is a medical device that received FDA 510(k) clearance on 1984-09-26. The listed applicant is American Dade. The 510(k) number is K843184.

When did STRATUS LIDOCAINE FLUOROMETRIC ENZYME receive FDA 510(k) clearance?

STRATUS LIDOCAINE FLUOROMETRIC ENZYME received FDA 510(k) clearance on 1984-09-26, under 510(k) number K843184.

Who is the listed applicant for STRATUS LIDOCAINE FLUOROMETRIC ENZYME?

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

What is the FDA product code for STRATUS LIDOCAINE FLUOROMETRIC ENZYME?

The FDA product code for STRATUS LIDOCAINE FLUOROMETRIC ENZYME is KLR.

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Other records listing American Dade 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.

K873051STRATUS(R) HFSH FLUOROMETRIC ENZYME IMMUNOASSAYK873171STRATUS(R) CK-MB FLUOROMETRIC ENZYME IMMUNOASSAYK873052STRATUS(R) HLH FLUOROMETRIC ENZYME IMMUNOASSAYK872789PARAMAX URINE/CSF CALIBRATORK872195DATA-FI DIMERTEST LATEX ASSAYK872196AQUEOUS BLOOD GAS/ELECTROLYTE CONTR LEV I,II & III

View all 149 devices →

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.K881116EASY-TEST EMIT(R) LIDOCAINE LIDO ITEM NO. 16641Diagnostic SystemsK853010COBAS REAGENT FOR LIDOCAINE & CALIBRATORSRoche Diagnostic Systems, 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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