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FDA 510(k)

EMIT 2000 N-ACETYLPROCAINAMIDE ASSAY AND CALIBRAT

K-Number: K922915 · 1992-08-24

ApplicantSyva Co.
Decision Date1992-08-24
Product CodeLAN
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

EMIT 2000 N-ACETYLPROCAINAMIDE ASSAY AND CALIBRAT is the device name listed in this FDA 510(k) record. The listed applicant is Syva Co.. It received FDA 510(k) clearance on 1992-08-24 under 510(k) number K922915. The device is classified under product code LAN. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EMIT 2000 N-ACETYLPROCAINAMIDE ASSAY AND CALIBRAT?

EMIT 2000 N-ACETYLPROCAINAMIDE ASSAY AND CALIBRAT is a medical device that received FDA 510(k) clearance on 1992-08-24. The listed applicant is Syva Co.. The 510(k) number is K922915.

When did EMIT 2000 N-ACETYLPROCAINAMIDE ASSAY AND CALIBRAT receive FDA 510(k) clearance?

EMIT 2000 N-ACETYLPROCAINAMIDE ASSAY AND CALIBRAT received FDA 510(k) clearance on 1992-08-24, under 510(k) number K922915.

Who is the listed applicant for EMIT 2000 N-ACETYLPROCAINAMIDE ASSAY AND CALIBRAT?

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 2000 N-ACETYLPROCAINAMIDE ASSAY AND CALIBRAT?

The FDA product code for EMIT 2000 N-ACETYLPROCAINAMIDE ASSAY AND CALIBRAT is LAN.

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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: LAN)

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.

K060738TDM N-ACETYLPROCAINAMIDERoche Diagnostics Corp.K032564DIMENSION N-ACETYLPROCAINAMIDE (NAPA) FLEX REAGENT CARTRIDGE METHOD, MODEL DF111Dade Behring, Inc.K011620EMIT 2000 N-ACETYLPROCAINAMIDE ASSAY, MODEL OSR4N229Syva Co., Dade Behring, Inc.K983812NAPA EIA ASSAYDiagnostic Reagents, Inc.K971713N-ACETYLPROCAINAMIDE ASSAY FOR THE BAYER IMMUNO 1 SYSTEMBayer Corp.K955422AXSYM N-ACETYLPROCAINAMIDEAbbott Laboratories

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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