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
K830653Substantially Equivalent

Polystyrene Microtiter Plate Immunosorb

Diagnostic Reagent Tech., Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K830653 is the FDA 510(k) clearance record for POLYSTYRENE MICROTITER PLATE IMMUNOSORB, a class II device, cleared for Diagnostic Reagent Tech. on under FDA product code DGO (Ige, Peroxidase, Antigen, Antiserum, Control). FDA records list 10 510(k) clearances for Diagnostic Reagent Tech., from to . As of , FDA records show no recalls naming K830653.

Clearance record

Decision date
Received
(38 days to decision)
Product code
DGO Ige, Peroxidase, Antigen, Antiserum, Control
Regulation
21 CFR 866.5510
Device class
Class II
Review panel
Immunology
Applicant
Diagnostic Reagent Tech. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code DGO

Trailing 12 months

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

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