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FDA 510(k)

IMMUNOCHEMICAL DETERMINATION OF IMMUNOGLOBULIN A

K-Number: K884040 · 1988-10-19

ApplicantOrion Diagnostica, Inc.
Decision Date1988-10-19
Product CodeCZP
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

IMMUNOCHEMICAL DETERMINATION OF IMMUNOGLOBULIN A is the device name listed in this FDA 510(k) record. The listed applicant is Orion Diagnostica, Inc.. It received FDA 510(k) clearance on 1988-10-19 under 510(k) number K884040. 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 IMMUNOCHEMICAL DETERMINATION OF IMMUNOGLOBULIN A?

IMMUNOCHEMICAL DETERMINATION OF IMMUNOGLOBULIN A is a medical device that received FDA 510(k) clearance on 1988-10-19. The listed applicant is Orion Diagnostica, Inc.. The 510(k) number is K884040.

When did IMMUNOCHEMICAL DETERMINATION OF IMMUNOGLOBULIN A receive FDA 510(k) clearance?

IMMUNOCHEMICAL DETERMINATION OF IMMUNOGLOBULIN A received FDA 510(k) clearance on 1988-10-19, under 510(k) number K884040.

Who is the listed applicant for IMMUNOCHEMICAL DETERMINATION OF IMMUNOGLOBULIN A?

The FDA 510(k) record lists Orion Diagnostica, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for IMMUNOCHEMICAL DETERMINATION OF IMMUNOGLOBULIN A?

The FDA product code for IMMUNOCHEMICAL DETERMINATION OF IMMUNOGLOBULIN A is CZP.

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Other records listing Orion Diagnostica, Inc. 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.

K942286DIARLEX ROTA-ADENOK914892SALIVA-STIMK904655PYLORISETK884147IMMUNOCHEMICAL DETERMINATION OF IMMUNOGLOBULIN MK884074IMMUNOCHEMICAL DETERMINATION OF IMMUNOGLOBULIN GK884075IMMUNOCHEMICAL DETERMINATION OF TRANSFERRIN

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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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