510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K820499Substantially Equivalent

Fitc Anti-Rabies Monoclonal Globulin

Centocor, Inc., Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K820499 is the FDA 510(k) clearance record for FITC ANTI-RABIES MONOCLONAL GLOBULIN, a class II device, cleared for Centocor, Inc. on under FDA product code GOI (Antiserum, Fluorescent, Rabies Virus). FDA records list 3 510(k) clearances for Centocor, Inc., from to . As of , FDA records show no recalls naming K820499.

Clearance record

Decision date
Received
(52 days to decision)
Product code
GOI Antiserum, Fluorescent, Rabies Virus
Regulation
21 CFR 866.3460
Device class
Class II
Review panel
Microbiology
Applicant
Centocor, Inc. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code GOI

Trailing 12 months

FDA records hold no clearances under product code GOI in the trailing twelve months.

FDA records show no clearances under product code GOI in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code GOI, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260