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FDA 510(k)

RITC-ANTI HUMAN IGA, IGG, KAPPA, LAMBDA

K-Number: K823121 · 1982-11-17

ApplicantAmico Lab, Inc.
Decision Date1982-11-17
Product CodeDFH
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

RITC-ANTI HUMAN IGA, IGG, KAPPA, LAMBDA is the device name listed in this FDA 510(k) record. The listed applicant is Amico Lab, Inc.. It received FDA 510(k) clearance on 1982-11-17 under 510(k) number K823121. The device is classified under product code DFH. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RITC-ANTI HUMAN IGA, IGG, KAPPA, LAMBDA?

RITC-ANTI HUMAN IGA, IGG, KAPPA, LAMBDA is a medical device that received FDA 510(k) clearance on 1982-11-17. The listed applicant is Amico Lab, Inc.. The 510(k) number is K823121.

When did RITC-ANTI HUMAN IGA, IGG, KAPPA, LAMBDA receive FDA 510(k) clearance?

RITC-ANTI HUMAN IGA, IGG, KAPPA, LAMBDA received FDA 510(k) clearance on 1982-11-17, under 510(k) number K823121.

Who is the listed applicant for RITC-ANTI HUMAN IGA, IGG, KAPPA, LAMBDA?

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

What is the FDA product code for RITC-ANTI HUMAN IGA, IGG, KAPPA, LAMBDA?

The FDA product code for RITC-ANTI HUMAN IGA, IGG, KAPPA, LAMBDA is DFH.

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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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