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FDA 510(k)

EMIT-STM OPIATE ASSAY

K-Number: K802615 · 1980-10-31

ApplicantSyva Co.
Decision Date1980-10-31
Product CodeDJE
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

EMIT-STM OPIATE 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 1980-10-31 under 510(k) number K802615. The device is classified under product code DJE. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EMIT-STM OPIATE ASSAY?

EMIT-STM OPIATE ASSAY is a medical device that received FDA 510(k) clearance on 1980-10-31. The listed applicant is Syva Co.. The 510(k) number is K802615.

When did EMIT-STM OPIATE ASSAY receive FDA 510(k) clearance?

EMIT-STM OPIATE ASSAY received FDA 510(k) clearance on 1980-10-31, under 510(k) number K802615.

Who is the listed applicant for EMIT-STM OPIATE 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-STM OPIATE ASSAY?

The FDA product code for EMIT-STM OPIATE ASSAY is DJE.

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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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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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