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FDA 510(k)

FITC GOAT ANTI-HUMAN IMMUNOGLOBULINS

K-Number: K832262 · 1983-10-31

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

Device Summary

FITC GOAT ANTI-HUMAN IMMUNOGLOBULINS 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 K832262. The device is classified under product code CZN. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FITC GOAT ANTI-HUMAN IMMUNOGLOBULINS?

FITC GOAT ANTI-HUMAN IMMUNOGLOBULINS 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 K832262.

When did FITC GOAT ANTI-HUMAN IMMUNOGLOBULINS receive FDA 510(k) clearance?

FITC GOAT ANTI-HUMAN IMMUNOGLOBULINS received FDA 510(k) clearance on 1983-10-31, under 510(k) number K832262.

Who is the listed applicant for FITC GOAT ANTI-HUMAN IMMUNOGLOBULINS?

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 IMMUNOGLOBULINS?

The FDA product code for FITC GOAT ANTI-HUMAN IMMUNOGLOBULINS is CZN.

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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.

K832256GOAT ANTI-HUMAN IMMUNOGLOBULINS-K832266FITC GOAT ANTI-HUMAN KAPPA AFFINITYK832265FITC GOAT ANTI-HUMAN IGM H CHAINK832260GOAT ANTI-HUMAN KAPPA AFFINITYK832258GOAT ANTI-HUMAN IGG Y CHAIN SPECIFICK832263FITC GOAT ANTI-HUMAN IGA A CHAIN

View all 14 devices →

Related Devices (Code: CZN)

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.

K891683TITAN GEL IFE FREE KAPPA/LAMBA LIGHT CHAIN ANTISERHelena LaboratoriesK855011QUANTIMETRIC PLUS C3 REAGENT KITKallestad Laboratories, Inc.K841815OPTIMATE IGA TESTMiles Laboratories, Inc.K832257GOAT ANTI-HUMAN IGA A CHAIN SPECIFICGelco Diagnostics, Inc.K831909RABBIT ANTISERUM TO HUMAN IGADako Corp.K831607FIAX IGA TEST KITIntl. Diagnostic Technology

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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