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FDA 510(k)

EMIT-STM URINE CONTROLS

K-Number: K802622 · 1980-10-20

ApplicantSyva Co.
Decision Date1980-10-20
Product Code
DecisionUnknown

Device Summary

EMIT-STM URINE CONTROLS is the device name listed in this FDA 510(k) record. The listed applicant is Syva Co.. It received FDA 510(k) clearance on 1980-10-20 under 510(k) number K802622. FDA Decision: Unknown.

Frequently Asked Questions

What is the EMIT-STM URINE CONTROLS?

EMIT-STM URINE CONTROLS is a medical device that received FDA 510(k) clearance on 1980-10-20. The listed applicant is Syva Co.. The 510(k) number is K802622.

When did EMIT-STM URINE CONTROLS receive FDA 510(k) clearance?

EMIT-STM URINE CONTROLS received FDA 510(k) clearance on 1980-10-20, under 510(k) number K802622.

Who is the listed applicant for EMIT-STM URINE CONTROLS?

The FDA 510(k) record lists Syva Co. as the applicant. This does not by itself establish the device manufacturer.

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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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