510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K831434Substantially Equivalent

ISO-Sep System

Berwick Medical Products, Inc., Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K831434 is the FDA 510(k) clearance record for ISO-SEP SYSTEM, a class II device, cleared for Berwick Medical Products, Inc. on under FDA product code CDP (Radioimmunoassay, Total Triiodothyronine). FDA records list 5 510(k) clearances for Berwick Medical Products, Inc., from to . As of , FDA records show no recalls naming K831434.

Clearance record

Decision date
Received
(57 days to decision)
Product code
CDP Radioimmunoassay, Total Triiodothyronine
Regulation
21 CFR 862.1710
Device class
Class II
Review panel
Clinical Chemistry
Applicant
Berwick Medical Products, Inc. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code CDP

Trailing 12 months

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

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