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FDA 510(k)

GOAT ANTI-HUMAN LAMBA AFFINITY

K-Number: K832261 · 1983-10-28

ApplicantGelco Diagnostics, Inc.
Decision Date1983-10-28
Product CodeDEH
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

GOAT ANTI-HUMAN LAMBA AFFINITY 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 1983-10-28 under 510(k) number K832261. The device is classified under product code DEH. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GOAT ANTI-HUMAN LAMBA AFFINITY?

GOAT ANTI-HUMAN LAMBA AFFINITY is a medical device that received FDA 510(k) clearance on 1983-10-28. The listed applicant is Gelco Diagnostics, Inc.. The 510(k) number is K832261.

When did GOAT ANTI-HUMAN LAMBA AFFINITY receive FDA 510(k) clearance?

GOAT ANTI-HUMAN LAMBA AFFINITY received FDA 510(k) clearance on 1983-10-28, under 510(k) number K832261.

Who is the listed applicant for GOAT ANTI-HUMAN LAMBA AFFINITY?

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 GOAT ANTI-HUMAN LAMBA AFFINITY?

The FDA product code for GOAT ANTI-HUMAN LAMBA AFFINITY is DEH.

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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

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Related Devices (Code: DEH)

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.

K172471VENTANA CD30 (Ber-H2) RxDx AssayVentana Medical Systems, Inc.K083601LAMBDA LIGHT CHAINSSENTINEL CH. SpAK033811FREELITE HUMAN KAPPA AND LAMBDA FREE KITS FOR USE ON THE OLYMPUS AU ANALYZERThe Binding Site, Ltd.K031016FREELITE HUMAN KAPPA AND LAMBDA FREE KITS FOR USE ON THE DAD BEHRING NEPHELOMETER IIThe Binding Site, Ltd.K023131FREELITE HUMAN LAMBDA FREE KITThe Binding Site, Ltd.K010440FREELITE LAMBDA FREE KITThe Binding Site, Ltd.

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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