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FDA 510(k)

IMMUNOGLOBULIN ASSAYS-IGG, IGA, IGM

K-Number: K823567 · 1982-12-30

ApplicantSyva Co.
Decision Date1982-12-30
Product CodeCZP
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

IMMUNOGLOBULIN ASSAYS-IGG, IGA, IGM is the device name listed in this FDA 510(k) record. The listed applicant is Syva Co.. It received FDA 510(k) clearance on 1982-12-30 under 510(k) number K823567. The device is classified under product code CZP. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IMMUNOGLOBULIN ASSAYS-IGG, IGA, IGM?

IMMUNOGLOBULIN ASSAYS-IGG, IGA, IGM is a medical device that received FDA 510(k) clearance on 1982-12-30. The listed applicant is Syva Co.. The 510(k) number is K823567.

When did IMMUNOGLOBULIN ASSAYS-IGG, IGA, IGM receive FDA 510(k) clearance?

IMMUNOGLOBULIN ASSAYS-IGG, IGA, IGM received FDA 510(k) clearance on 1982-12-30, under 510(k) number K823567.

Who is the listed applicant for IMMUNOGLOBULIN ASSAYS-IGG, IGA, IGM?

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 IMMUNOGLOBULIN ASSAYS-IGG, IGA, IGM?

The FDA product code for IMMUNOGLOBULIN ASSAYS-IGG, IGA, IGM is CZP.

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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: CZP)

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.

K193525Yumizen C1200 Immunoglobulin A, Yumizen C1200 Immunoglobulin G, Yumizen C1200 Immunoglobulin MHORIBA ABX SASK060130IMMAGE SYSTEMS LOW CONCENTRATION IMMUNOGLOBULIN A REAGENTBeckman Coulter, Inc.K040435ROCHE DIAGNOSTICS TINA-QUANT IGA GEN.2Roche Diagnostics Corp.K024038N LATEX IGADade Behring, Inc.K993927WAKO IGA II-HA, IMMUNOGLOBULIN CALIBRATOR SET, IMMUNOGLOBULIN STANDRADWako Chemicals USA, Inc.K983359IGAAbbott Laboratories

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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