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FDA 510(k)

FITC ANTI-RABIES MONOCLONAL GLOBULIN

K-Number: K820499 · 1982-04-16

ApplicantCentocor, Inc.
Decision Date1982-04-16
Product CodeGOI
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

FITC ANTI-RABIES MONOCLONAL GLOBULIN is the device name listed in this FDA 510(k) record. The listed applicant is Centocor, Inc.. It received FDA 510(k) clearance on 1982-04-16 under 510(k) number K820499. The device is classified under product code GOI. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FITC ANTI-RABIES MONOCLONAL GLOBULIN?

FITC ANTI-RABIES MONOCLONAL GLOBULIN is a medical device that received FDA 510(k) clearance on 1982-04-16. The listed applicant is Centocor, Inc.. The 510(k) number is K820499.

When did FITC ANTI-RABIES MONOCLONAL GLOBULIN receive FDA 510(k) clearance?

FITC ANTI-RABIES MONOCLONAL GLOBULIN received FDA 510(k) clearance on 1982-04-16, under 510(k) number K820499.

Who is the listed applicant for FITC ANTI-RABIES MONOCLONAL GLOBULIN?

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

What is the FDA product code for FITC ANTI-RABIES MONOCLONAL GLOBULIN?

The FDA product code for FITC ANTI-RABIES MONOCLONAL GLOBULIN is GOI.

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Other records listing Centocor, 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.

K963803CENTOCOR CA 15-3 RIA MODEL NO. 800-033K954997CENTOCOR AGGRESTAT, COLLAGEN REAGENT, CONTROL REAGENT

Related Devices (Code: GOI)

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.

K972975LIGHT DIAGNOSTICS RABIES DFA REAGENTLight Diagnostics

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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