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
K843302Substantially Equivalent

New Allerg. Coated Microfilter Well Stri

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

K843302 is the FDA 510(k) clearance record for NEW ALLERG. COATED MICROFILTER WELL STRI, a class II device, cleared for Diagnostic Reagent Tech. on under FDA product code DHB (System, Test, Radioallergosorbent (Rast) Immunological). FDA records list 10 510(k) clearances for Diagnostic Reagent Tech., from to . As of , FDA records show no recalls naming K843302.

Clearance record

Decision date
Received
(42 days to decision)
Product code
DHB System, Test, Radioallergosorbent (Rast) Immunological
Regulation
21 CFR 866.5750
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 DHB

Trailing 12 months
7 clearances under product code DHB in the twelve months to October 2026, July 2026 the highest month at 2.
Show the numbers
Monthly 510(k) clearances under FDA product code DHB, trailing twelve months
MonthClearances
November 20250
December 20251
January 20261
February 20260
March 20260
April 20260
May 20261
June 20261
July 20262
August 20260
September 20261
October 20260