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FDA 510(k)

EMIT-AND METHOTREXATE ASSAY

K-Number: K811459 · 1981-06-09

ApplicantSyva Co.
Decision Date1981-06-09
Product CodeLAO
DecisionSubstantially Equivalent

Device Summary

EMIT-AND METHOTREXATE 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 1981-06-09 under 510(k) number K811459. The device is classified under product code LAO. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EMIT-AND METHOTREXATE ASSAY?

EMIT-AND METHOTREXATE ASSAY is a medical device that received FDA 510(k) clearance on 1981-06-09. The listed applicant is Syva Co.. The 510(k) number is K811459.

When did EMIT-AND METHOTREXATE ASSAY receive FDA 510(k) clearance?

EMIT-AND METHOTREXATE ASSAY received FDA 510(k) clearance on 1981-06-09, under 510(k) number K811459.

Who is the listed applicant for EMIT-AND METHOTREXATE 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-AND METHOTREXATE ASSAY?

The FDA product code for EMIT-AND METHOTREXATE ASSAY is LAO.

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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: LAO)

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.

K233454ONLINE TDM MethotrexateRoche Diagnostics OperationsK232017ARK Methotrexate II AssayArk Diagnostics, Inc.K163359ARK Methotrexate AssayArk Diagnostics, Inc.K111904ARK METHOTREXATE ASSAY, ARK METHOTREXATE CALIBRATOR, ARK METHOTREXATE CONTROL, ARK METHOTREXATE CONTROL (CALIBRATION RANArk Diagnostics, Inc.K932615TDX(R)/TDX(R)FLX(R)MEHTOTREXATE IIAbbott LaboratoriesK884744ACA DU PONT METHOTREXATE (MTHO) METHODE.I. Dupont DE Nemours & Co., 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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