510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K771583Substantially Equivalent

Fluorescent Anti. Anti-Human C3

Burroughs Wellcome Co., Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K771583 is the FDA 510(k) clearance record for FLUORESCENT ANTI. ANTI-HUMAN C3, a class II device, cleared for Burroughs Wellcome Co. on under FDA product code DAC (Complement C3b Activator, Antigen, Antiserum, Control). FDA records list 17 510(k) clearances for Burroughs Wellcome Co., from to . As of , FDA records show no recalls naming K771583.

Clearance record

Decision date
Received
(15 days to decision)
Product code
DAC Complement C3b Activator, Antigen, Antiserum, Control
Regulation
21 CFR 866.5260
Device class
Class II
Review panel
Immunology
Applicant
Burroughs Wellcome Co. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code DAC

Trailing 12 months

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

FDA records show no clearances under product code DAC in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code DAC, 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