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510(k) K820499

FITC ANTI-RABIES MONOCLONAL GLOBULIN by Centocor, Inc. — Product Code GOI

K820499 is an FDA 510(k) premarket notification submitted by Centocor, Inc. for the device "FITC ANTI-RABIES MONOCLONAL GLOBULIN". The FDA issued a decision of Substantially Equivalent on April 16, 1982. The device falls under product code GOI (Antiserum, Fluorescent, Rabies Virus), a Class II device regulated under 21 CFR 866.3460. Centocor, Inc. has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 16, 1982
Date Received
February 23, 1982
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Antiserum, Fluorescent, Rabies Virus
Device Class
Class II
Regulation Number
866.3460
Review Panel
MI
Submission Type

Other clearances by Centocor, Inc.

  • K963803 — CENTOCOR CA 15-3 RIA MODEL NO. 800-033 (May 23, 1997)
  • K954997 — CENTOCOR AGGRESTAT, COLLAGEN REAGENT, CONTROL REAGENT (January 24, 1996)

Other clearances for product code GOI

  • K972975 — LIGHT DIAGNOSTICS RABIES DFA REAGENT (December 22, 1998)

FDA data resources