510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K832256Substantially Equivalent

Goat Anti-Human Immunoglobulins-

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

K832256 is the FDA 510(k) clearance record for GOAT ANTI-HUMAN IMMUNOGLOBULINS-, a class II device, cleared for Gelco Diagnostics, Inc. on under FDA product code DFH (Kappa, Antigen, Antiserum, Control). FDA records list 14 510(k) clearances for Gelco Diagnostics, Inc., from to . As of , FDA records show no recalls naming K832256.

Clearance record

Decision date
Received
(123 days to decision)
Product code
DFH Kappa, Antigen, Antiserum, Control
Regulation
21 CFR 866.5550
Device class
Class II
Review panel
Immunology
Applicant
Gelco Diagnostics, Inc. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code DFH

Trailing 12 months
1 clearance under product code DFH in the twelve months to October 2026, December 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code DFH, trailing twelve months
MonthClearances
November 20250
December 20251
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260