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FDA 510(k)

GEMSTAR IPA THEOPHYLLINE TEST KIT

K-Number: K853372 · 1985-09-04

ApplicantElectro-Nucleonics Laboratories, Inc.
Decision Date1985-09-04
Product CodeKLS
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

GEMSTAR IPA THEOPHYLLINE TEST KIT is the device name listed in this FDA 510(k) record. The listed applicant is Electro-Nucleonics Laboratories, Inc.. It received FDA 510(k) clearance on 1985-09-04 under 510(k) number K853372. 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 GEMSTAR IPA THEOPHYLLINE TEST KIT?

GEMSTAR IPA THEOPHYLLINE TEST KIT is a medical device that received FDA 510(k) clearance on 1985-09-04. The listed applicant is Electro-Nucleonics Laboratories, Inc.. The 510(k) number is K853372.

When did GEMSTAR IPA THEOPHYLLINE TEST KIT receive FDA 510(k) clearance?

GEMSTAR IPA THEOPHYLLINE TEST KIT received FDA 510(k) clearance on 1985-09-04, under 510(k) number K853372.

Who is the listed applicant for GEMSTAR IPA THEOPHYLLINE TEST KIT?

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

What is the FDA product code for GEMSTAR IPA THEOPHYLLINE TEST KIT?

The FDA product code for GEMSTAR IPA THEOPHYLLINE TEST KIT is KLS.

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Other records listing Electro-Nucleonics Laboratories, 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.

K873925VIRGO(TM) MEASLES IGG ELISAK873617GEMSTAR II SYSTEMK873416MULTI-ACCESS REAGENT DISPENSERK873358GEMENI URIC ACID U.V.K873088VIRGO(TM) RUBELLA IGG ELISAK871905TOXOPLASMA GONDII IGG ELISA

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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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