510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K962409Substantially Equivalent

Olympus C3 Immunoturbidimetric Regent

OLYMPUS Corporation of the Americas, Melville NY / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K962409 is the FDA 510(k) clearance record for OLYMPUS C3 IMMUNOTURBIDIMETRIC REGENT, a class II device, cleared for Olympus America, Inc. on under FDA product code CZW (Complement C3, Antigen, Antiserum, Control). FDA records list 150 510(k) clearances for OLYMPUS Corporation of the Americas, from to . As of , FDA records show no recalls naming K962409.

Clearance record

Decision date
Received
(119 days to decision)
Product code
CZW Complement C3, Antigen, Antiserum, Control
Regulation
21 CFR 866.5240
Device class
Class II
Review panel
Immunology
Applicant
Olympus America, Inc. Two Corporate Center Dr., Melville NY
510(k) summary
Statement
Third party review
No

Clearances, product code CZW

Trailing 12 months

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

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