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FDA 510(k)

THEOPHYLLINE ENZYME IMMUNOASSAY

K-Number: K952596 · 1995-08-11

ApplicantDiagnostic Reagents, Inc.
Decision Date1995-08-11
Product CodeKLS
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

THEOPHYLLINE ENZYME IMMUNOASSAY is the device name listed in this FDA 510(k) record. The listed applicant is Diagnostic Reagents, Inc.. It received FDA 510(k) clearance on 1995-08-11 under 510(k) number K952596. The device is classified under product code KLS. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the THEOPHYLLINE ENZYME IMMUNOASSAY?

THEOPHYLLINE ENZYME IMMUNOASSAY is a medical device that received FDA 510(k) clearance on 1995-08-11. The listed applicant is Diagnostic Reagents, Inc.. The 510(k) number is K952596.

When did THEOPHYLLINE ENZYME IMMUNOASSAY receive FDA 510(k) clearance?

THEOPHYLLINE ENZYME IMMUNOASSAY received FDA 510(k) clearance on 1995-08-11, under 510(k) number K952596.

Who is the listed applicant for THEOPHYLLINE ENZYME IMMUNOASSAY?

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

What is the FDA product code for THEOPHYLLINE ENZYME IMMUNOASSAY?

The FDA product code for THEOPHYLLINE ENZYME IMMUNOASSAY is KLS.

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Other records listing Diagnostic Reagents, Inc. 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.

K983268MODIFICATION OF TRICYCLIC SERUM TOX EIA ASSAYK983812NAPA EIA ASSAYK983323DIGOXIN IMMUNOASSAYK983280VANCOMYCIN EIA ASSAYK983159DRUGS OF ABUSE URINE CALIBRATORS AND CONTROLSK973102LIDOCAINE EIA ASSAY

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Related Devices (Code: KLS)

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.

K042520VITROS CHEMISTRY PRODUCTS CAFFN REAGENT KIT AND TDM PERFORMANCE VERIFIERS I, II AND IIIOrtho-Clinical Diagnostics, Inc.K042407EMIT CAFFEINE ASSAYDade Behring, Inc.K020740ROCHE ONLINE THEOPHYLLINERoche Diagnostics Corp.K011771RANDOX THEOPHYLLINERandox Laboratories, Ltd.K013272ACS: 180 AND ADVIA CENTAUR THEOPHYLLINE 2 ASSAYBayer Corp.K011166MODIFICATION TO EMIT 2000 THEOPHYLLINE ASSAY, MODEL OSR 4P229Syva Co., Dade Behring, 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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