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FDA 510(k)

FITC GOAT ANTI-HUMAN LAMBA

K-Number: K832267 · 1983-10-31

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

Device Summary

FITC GOAT ANTI-HUMAN LAMBA 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 K832267. The device is classified under product code DES. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FITC GOAT ANTI-HUMAN LAMBA?

FITC GOAT ANTI-HUMAN LAMBA 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 K832267.

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

FITC GOAT ANTI-HUMAN LAMBA received FDA 510(k) clearance on 1983-10-31, under 510(k) number K832267.

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

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 LAMBA?

The FDA product code for FITC GOAT ANTI-HUMAN LAMBA is DES.

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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: DES)

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.

K831903FLUORESCEIN CONJUGATED IMMUNOGLOBULINDako 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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