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FDA 510(k)

ACCUMETER THEOPHYLLINE TEST

K-Number: K972495 · 1997-10-10

ApplicantChemtrak, Inc.
Decision Date1997-10-10
Product CodeKLS
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

ACCUMETER THEOPHYLLINE TEST is the device name listed in this FDA 510(k) record. The listed applicant is Chemtrak, Inc.. It received FDA 510(k) clearance on 1997-10-10 under 510(k) number K972495. 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 ACCUMETER THEOPHYLLINE TEST?

ACCUMETER THEOPHYLLINE TEST is a medical device that received FDA 510(k) clearance on 1997-10-10. The listed applicant is Chemtrak, Inc.. The 510(k) number is K972495.

When did ACCUMETER THEOPHYLLINE TEST receive FDA 510(k) clearance?

ACCUMETER THEOPHYLLINE TEST received FDA 510(k) clearance on 1997-10-10, under 510(k) number K972495.

Who is the listed applicant for ACCUMETER THEOPHYLLINE TEST?

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

What is the FDA product code for ACCUMETER THEOPHYLLINE TEST?

The FDA product code for ACCUMETER THEOPHYLLINE TEST is KLS.

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Other records listing Chemtrak, 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.

K965099ACCUMETER H. PYLORI TESTK960478ACCUMETER H. PYLORI TESTK943279ACCUMETER HDL CHOLESTEROL TESTK943599CHEM TRAK ACCUMETERK914432ACCUMETER(R) CHOLESTEROL SELF-TESTK905405CHEMTRAK ACCUMETER CHOLESTEROL TEST

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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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