510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K834605Substantially Equivalent

C4 Antigen Antibody Control

Technicon Instruments Corp., Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K834605 is the FDA 510(k) clearance record for C4 ANTIGEN ANTIBODY CONTROL, a class II device, cleared for Technicon Instruments Corp. on under FDA product code DBI (Complement C4, Antigen, Antiserum, Control). FDA records list 157 510(k) clearances for Technicon Instruments Corp., from to . As of , FDA records show no recalls naming K834605.

Clearance record

Decision date
Received
(116 days to decision)
Product code
DBI Complement C4, Antigen, Antiserum, Control
Regulation
21 CFR 866.5240
Device class
Class II
Review panel
Immunology
Applicant
Technicon Instruments Corp. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code DBI

Trailing 12 months

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

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