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FDA 510(k)

EMIT ST. URINE COCAINE METABOLITE

K-Number: K834549 · 1984-03-19

ApplicantSyva Co.
Decision Date1984-03-19
Product CodeDIO
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

EMIT ST. URINE COCAINE METABOLITE is the device name listed in this FDA 510(k) record. The listed applicant is Syva Co.. It received FDA 510(k) clearance on 1984-03-19 under 510(k) number K834549. The device is classified under product code DIO. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EMIT ST. URINE COCAINE METABOLITE?

EMIT ST. URINE COCAINE METABOLITE is a medical device that received FDA 510(k) clearance on 1984-03-19. The listed applicant is Syva Co.. The 510(k) number is K834549.

When did EMIT ST. URINE COCAINE METABOLITE receive FDA 510(k) clearance?

EMIT ST. URINE COCAINE METABOLITE received FDA 510(k) clearance on 1984-03-19, under 510(k) number K834549.

Who is the listed applicant for EMIT ST. URINE COCAINE METABOLITE?

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 ST. URINE COCAINE METABOLITE?

The FDA product code for EMIT ST. URINE COCAINE METABOLITE is DIO.

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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: DIO)

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.

K213211Carolina Liquid Chemistries Cocaine and Cocaine Metabolite Enzyme Immunoassay (COCM) Test SystemCarolina Liquid Chemistries Corp.K211973DRI Cocaine Metabolite AssayMicrogenics CorporationK191638Pointe Scientific Cocaine Metabolite Enzyme ImmunoassayMedtest DXK181499DRI Cocaine Metabolite AssayMicrogenics CorporationK170293Emit II Plus Cocaine Metabolite AssaySiemens Healthcare Diagnostics, Inc.K163570Carolina Liquid Chemistries Cocaine and Cocaine Metabolite Test System (COCM)Carolina Liquid Chemistries Corporation

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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