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FDA 510(k)

ACCULEVEL THEOPHYLLINE TEST

K-Number: K844642 · 1985-03-19

ApplicantSyva Co.
Decision Date1985-03-19
Product CodeKLS
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

ACCULEVEL THEOPHYLLINE TEST is the device name listed in this FDA 510(k) record. The listed applicant is Syva Co.. It received FDA 510(k) clearance on 1985-03-19 under 510(k) number K844642. 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 ACCULEVEL THEOPHYLLINE TEST?

ACCULEVEL THEOPHYLLINE TEST is a medical device that received FDA 510(k) clearance on 1985-03-19. The listed applicant is Syva Co.. The 510(k) number is K844642.

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

ACCULEVEL THEOPHYLLINE TEST received FDA 510(k) clearance on 1985-03-19, under 510(k) number K844642.

Who is the listed applicant for ACCULEVEL THEOPHYLLINE TEST?

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

What is the FDA product code for ACCULEVEL THEOPHYLLINE TEST?

The FDA product code for ACCULEVEL THEOPHYLLINE TEST is KLS.

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Other records listing Syva Co. 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.

K011878EMIT (R) TOX SALICYLIC ASSAY, MODEL 7SO19UL, EMIT (R) TOX SALICYLIC ACID CALIBRATORS, MODEL 7S109ULK012257EMIT II PLUS MONOCLONAL AMPHETAMINE/METHAMPHETAMINE ASSAY MODEL OSR9C229K011947EMIT 2000 VALPROIC ACID ASSAY, MODEL OSR4G229ULK011528EMIT 2000 PHENOBARBITAL ASSAY, MODEL OSR4D229K011347EMIT 2000 PHENYTOIN ASSAY, MODEL 0SR4A229K993980SYVA EMIT II PLUS ETHYL ALCOHOL ASSAY, MODELS 9K309UL/9K409UL

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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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