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FDA 510(k)

EMIT(R) 2000 THEOPHYLLINE ASSAY/CALIBRATORS

K-Number: K913123 · 1991-09-19

ApplicantSyva Co.
Decision Date1991-09-19
Product CodeKLS
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

EMIT(R) 2000 THEOPHYLLINE ASSAY/CALIBRATORS is the device name listed in this FDA 510(k) record. The listed applicant is Syva Co.. It received FDA 510(k) clearance on 1991-09-19 under 510(k) number K913123. 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 EMIT(R) 2000 THEOPHYLLINE ASSAY/CALIBRATORS?

EMIT(R) 2000 THEOPHYLLINE ASSAY/CALIBRATORS is a medical device that received FDA 510(k) clearance on 1991-09-19. The listed applicant is Syva Co.. The 510(k) number is K913123.

When did EMIT(R) 2000 THEOPHYLLINE ASSAY/CALIBRATORS receive FDA 510(k) clearance?

EMIT(R) 2000 THEOPHYLLINE ASSAY/CALIBRATORS received FDA 510(k) clearance on 1991-09-19, under 510(k) number K913123.

Who is the listed applicant for EMIT(R) 2000 THEOPHYLLINE ASSAY/CALIBRATORS?

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 EMIT(R) 2000 THEOPHYLLINE ASSAY/CALIBRATORS?

The FDA product code for EMIT(R) 2000 THEOPHYLLINE ASSAY/CALIBRATORS 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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