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FDA 510(k)

FITC GOAT ANTI-HUMAN IGA A CHAIN

K-Number: K832263 · 1983-10-31

ApplicantGelco Diagnostics, Inc.
Decision Date1983-10-31
Product CodeCZP
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

FITC GOAT ANTI-HUMAN IGA A CHAIN is the device name listed in this FDA 510(k) record. The listed applicant is Gelco Diagnostics, Inc.. It received FDA 510(k) clearance on 1983-10-31 under 510(k) number K832263. 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 FITC GOAT ANTI-HUMAN IGA A CHAIN?

FITC GOAT ANTI-HUMAN IGA A CHAIN is a medical device that received FDA 510(k) clearance on 1983-10-31. The listed applicant is Gelco Diagnostics, Inc.. The 510(k) number is K832263.

When did FITC GOAT ANTI-HUMAN IGA A CHAIN receive FDA 510(k) clearance?

FITC GOAT ANTI-HUMAN IGA A CHAIN received FDA 510(k) clearance on 1983-10-31, under 510(k) number K832263.

Who is the listed applicant for FITC GOAT ANTI-HUMAN IGA A CHAIN?

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

What is the FDA product code for FITC GOAT ANTI-HUMAN IGA A CHAIN?

The FDA product code for FITC GOAT ANTI-HUMAN IGA A CHAIN is CZP.

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Other records listing Gelco Diagnostics, 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.

K832266FITC GOAT ANTI-HUMAN KAPPA AFFINITYK832265FITC GOAT ANTI-HUMAN IGM H CHAINK832260GOAT ANTI-HUMAN KAPPA AFFINITYK832258GOAT ANTI-HUMAN IGG Y CHAIN SPECIFICK832267FITC GOAT ANTI-HUMAN LAMBAK832256GOAT ANTI-HUMAN IMMUNOGLOBULINS-

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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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