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FDA 510(k)

ENZYMATIC THEOPHYLLINE REAGENT, #500-82

K-Number: K901510 · 1990-06-12

ApplicantDiagnostic Chemicals, Ltd. (Usa)
Decision Date1990-06-12
Product CodeKLS
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

ENZYMATIC THEOPHYLLINE REAGENT, #500-82 is the device name listed in this FDA 510(k) record. The listed applicant is Diagnostic Chemicals, Ltd. (Usa). It received FDA 510(k) clearance on 1990-06-12 under 510(k) number K901510. 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 ENZYMATIC THEOPHYLLINE REAGENT, #500-82?

ENZYMATIC THEOPHYLLINE REAGENT, #500-82 is a medical device that received FDA 510(k) clearance on 1990-06-12. The listed applicant is Diagnostic Chemicals, Ltd. (Usa). The 510(k) number is K901510.

When did ENZYMATIC THEOPHYLLINE REAGENT, #500-82 receive FDA 510(k) clearance?

ENZYMATIC THEOPHYLLINE REAGENT, #500-82 received FDA 510(k) clearance on 1990-06-12, under 510(k) number K901510.

Who is the listed applicant for ENZYMATIC THEOPHYLLINE REAGENT, #500-82?

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

What is the FDA product code for ENZYMATIC THEOPHYLLINE REAGENT, #500-82?

The FDA product code for ENZYMATIC THEOPHYLLINE REAGENT, #500-82 is KLS.

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Other records listing Diagnostic Chemicals, Ltd. (Usa) 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.

K022538IMMUNODIP URINARY ALBUMIN SCREEN ASSAY, CATALOGUE NUMBER 790-25K974874BILIRUBIN-SL (TOTAL) ASSAYK932556AMMONIA ASSAY CAT. NO. 200-02K932766HDL-CHOLESTRAL(DEXTRAN SULFATE/MAGNESIUM)K932555DC-LINEATE CAT. NO. SE-091K925877DC-UIBC-CAL

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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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