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FDA 510(k)

EMIT QST ACETAMINOPHEN ASSAY

K-Number: K844962 · 1985-01-18

ApplicantSyva Co.
Decision Date1985-01-18
Product CodeLDP
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

EMIT QST ACETAMINOPHEN 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 1985-01-18 under 510(k) number K844962. The device is classified under product code LDP. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EMIT QST ACETAMINOPHEN ASSAY?

EMIT QST ACETAMINOPHEN ASSAY is a medical device that received FDA 510(k) clearance on 1985-01-18. The listed applicant is Syva Co.. The 510(k) number is K844962.

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

EMIT QST ACETAMINOPHEN ASSAY received FDA 510(k) clearance on 1985-01-18, under 510(k) number K844962.

Who is the listed applicant for EMIT QST ACETAMINOPHEN 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 QST ACETAMINOPHEN ASSAY?

The FDA product code for EMIT QST ACETAMINOPHEN ASSAY is LDP.

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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: LDP)

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.

K261364Atellica CH Acetaminophen 2 (ACTM)Siemens Healthcare Diagnostics, Inc.K202644AcetaminophenSekisui Diagnostics P.E.I., Inc.K180835SEKURE Acetaminophen L3K AssaySekisui Diagnostics P.E.I., Inc.K110726ROCHE ACETAMINOPHEN ASSAYRoche DiagnosticsK100200ADVIA CHEMISTRY ACETAMINOPHEN REAGENT, MODEL REF 07989138Siemens Healthcare DiagnosticsK081938ACETAMINOPHEN L3K ASSAY, AND ACETAMINOPHEN L3K ASSAY, MODELS 506-10, 506-30Genzyme Diagnostics P.E.I., Inc.

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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