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FDA 510(k)

STRATUS N-ACETYLPROCAINAMIDE FLUOROMETRIC ENZYME I

K-Number: K853547 · 1985-09-16

ApplicantAmerican Dade
Decision Date1985-09-16
Product CodeLAN
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

STRATUS N-ACETYLPROCAINAMIDE FLUOROMETRIC ENZYME I is the device name listed in this FDA 510(k) record. The listed applicant is American Dade. It received FDA 510(k) clearance on 1985-09-16 under 510(k) number K853547. The device is classified under product code LAN. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the STRATUS N-ACETYLPROCAINAMIDE FLUOROMETRIC ENZYME I?

STRATUS N-ACETYLPROCAINAMIDE FLUOROMETRIC ENZYME I is a medical device that received FDA 510(k) clearance on 1985-09-16. The listed applicant is American Dade. The 510(k) number is K853547.

When did STRATUS N-ACETYLPROCAINAMIDE FLUOROMETRIC ENZYME I receive FDA 510(k) clearance?

STRATUS N-ACETYLPROCAINAMIDE FLUOROMETRIC ENZYME I received FDA 510(k) clearance on 1985-09-16, under 510(k) number K853547.

Who is the listed applicant for STRATUS N-ACETYLPROCAINAMIDE FLUOROMETRIC ENZYME I?

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 N-ACETYLPROCAINAMIDE FLUOROMETRIC ENZYME I?

The FDA product code for STRATUS N-ACETYLPROCAINAMIDE FLUOROMETRIC ENZYME I is LAN.

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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

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Related Devices (Code: LAN)

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.

K060738TDM N-ACETYLPROCAINAMIDERoche Diagnostics Corp.K032564DIMENSION N-ACETYLPROCAINAMIDE (NAPA) FLEX REAGENT CARTRIDGE METHOD, MODEL DF111Dade Behring, Inc.K011620EMIT 2000 N-ACETYLPROCAINAMIDE ASSAY, MODEL OSR4N229Syva Co., Dade Behring, Inc.K983812NAPA EIA ASSAYDiagnostic Reagents, Inc.K971713N-ACETYLPROCAINAMIDE ASSAY FOR THE BAYER IMMUNO 1 SYSTEMBayer Corp.K955422AXSYM N-ACETYLPROCAINAMIDEAbbott Laboratories

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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