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FDA 510(k)

GOAT ANTI-HUMAN KAPPA AFFINITY

K-Number: K832260 · 1983-10-31

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

Device Summary

GOAT ANTI-HUMAN KAPPA 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 1983-10-31 under 510(k) number K832260. The device is classified under product code DEO. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GOAT ANTI-HUMAN KAPPA AFFINITY?

GOAT ANTI-HUMAN KAPPA AFFINITY 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 K832260.

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

GOAT ANTI-HUMAN KAPPA AFFINITY received FDA 510(k) clearance on 1983-10-31, under 510(k) number K832260.

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

The FDA product code for GOAT ANTI-HUMAN KAPPA AFFINITY is DEO.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

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 CHAINK832258GOAT ANTI-HUMAN IGG Y CHAIN SPECIFICK832267FITC GOAT ANTI-HUMAN LAMBAK832263FITC GOAT ANTI-HUMAN IGA A CHAIN

View all 14 devices →

Related Devices (Code: DEO)

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.

K831904RABBIT ANTISERUM TO HUMAN KAPPA LIGHTDako Corp.

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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