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FDA 510(k)

EMIT N-ACETYLPROCAINAMIDE ASSAY

K-Number: K781378 · 1978-10-10

ApplicantSyva Co.
Decision Date1978-10-10
Product CodeLAN
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

EMIT N-ACETYLPROCAINAMIDE ASSAY is the device name listed in this FDA 510(k) record. The listed applicant is Syva Co.. It received FDA 510(k) clearance on 1978-10-10 under 510(k) number K781378. 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 N-ACETYLPROCAINAMIDE ASSAY?

EMIT N-ACETYLPROCAINAMIDE ASSAY is a medical device that received FDA 510(k) clearance on 1978-10-10. The listed applicant is Syva Co.. The 510(k) number is K781378.

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

EMIT N-ACETYLPROCAINAMIDE ASSAY received FDA 510(k) clearance on 1978-10-10, under 510(k) number K781378.

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

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 N-ACETYLPROCAINAMIDE ASSAY?

The FDA product code for EMIT N-ACETYLPROCAINAMIDE ASSAY 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

View all 448 devices →

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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