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
K800364Substantially Equivalent

Ultrasonic Diagnostic System, Mod. 202

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

K800364 is the FDA 510(k) clearance record for ULTRASONIC DIAGNOSTIC SYSTEM, MOD. 202, a class II device, cleared for Hoffrel Instruments, Inc. on under FDA product code DKX (Thin Layer Chromatography, Barbiturate). FDA records list 12 510(k) clearances for Hoffrel Instruments, Inc., from to . As of , FDA records show no recalls naming K800364.

Clearance record

Decision date
Received
(21 days to decision)
Product code
DKX Thin Layer Chromatography, Barbiturate
Regulation
21 CFR 862.3150
Device class
Class II
Review panel
Clinical Toxicology
Applicant
Hoffrel Instruments, Inc. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code DKX

Trailing 12 months

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

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