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FDA 510(k)

EMIT NORTRIPTYLINE ASSAY

K-Number: K844952 · 1985-06-28

ApplicantSyva Co.
Decision Date1985-06-28
Product CodeLFG
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

EMIT NORTRIPTYLINE 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 1985-06-28 under 510(k) number K844952. The device is classified under product code LFG. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EMIT NORTRIPTYLINE ASSAY?

EMIT NORTRIPTYLINE ASSAY is a medical device that received FDA 510(k) clearance on 1985-06-28. The listed applicant is Syva Co.. The 510(k) number is K844952.

When did EMIT NORTRIPTYLINE ASSAY receive FDA 510(k) clearance?

EMIT NORTRIPTYLINE ASSAY received FDA 510(k) clearance on 1985-06-28, under 510(k) number K844952.

Who is the listed applicant for EMIT NORTRIPTYLINE 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 NORTRIPTYLINE ASSAY?

The FDA product code for EMIT NORTRIPTYLINE ASSAY is LFG.

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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: LFG)

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.

K112395WONDFO PHENCYCLIDINE URINE TEST, TRICYCLIC ANTIDEPRESSANTS URINE TESTGuangzhou Wondfo Biotech Co., Ltd.K072062UCP MULTIPLE DRUG SCREEN TEST CUPSUcp Biosciences, Inc.K061457UCP RAPID DRUG SCREENING TRICYCLIC ANTIDEPRESSANT, PROPOXYPHENE TESTSUcp Biosciences, Inc.K021526ACON TCA ONE STEP TRICYCLIC ANTIDEPRESSANT TEST STRIP AND DEVICEACON Laboratories, Inc.K011545VERDICT -II TCA, VERDICT-II MTDMedtox Diagnostics, Inc.K980249ACCUSIGN TCA, BIOSIGN TCA, STAUS DS TCAPrinceton BioMeditech Corp.

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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