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FDA 510(k)

STRATUS QUINIDINE FLUOROMETRIC ENZYME

K-Number: K843237 · 1984-09-12

ApplicantAmerican Dade
Decision Date1984-09-12
Product CodeLBZ
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

STRATUS QUINIDINE 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 1984-09-12 under 510(k) number K843237. The device is classified under product code LBZ. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the STRATUS QUINIDINE FLUOROMETRIC ENZYME?

STRATUS QUINIDINE FLUOROMETRIC ENZYME is a medical device that received FDA 510(k) clearance on 1984-09-12. The listed applicant is American Dade. The 510(k) number is K843237.

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

STRATUS QUINIDINE FLUOROMETRIC ENZYME received FDA 510(k) clearance on 1984-09-12, under 510(k) number K843237.

Who is the listed applicant for STRATUS QUINIDINE 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 QUINIDINE FLUOROMETRIC ENZYME?

The FDA product code for STRATUS QUINIDINE FLUOROMETRIC ENZYME is LBZ.

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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: LBZ)

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.

K052826QMS QUINIDINE. QMS QUINIDINE CALIBRATORSSeradyn, Inc.K032332ROCHE ONLINE TDM QUINIDINERoche Diagnostics Corp.K011605EMIT 2000 QUINIDINE ASSAY, MODEL OSR4Q229Syva Co., Dade Behring, Inc.K964116QUINIDINE ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM (IN VITRO DIAGNOSTIC SYSTEM)Bayer Corp.K964212QUINIDINE ENZYME IMMUNOASSAYDiagnostic Reagents, Inc.K955568INNOFLUOR QUINIDINE ASSAY SYSTEMOxis Intl., 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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