510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K833319Substantially Equivalent

Bio-Rex 70 Resin 100-200 Mesh Ph6.2

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

K833319 is the FDA 510(k) clearance record for BIO-REX 70 RESIN 100-200 MESH PH6.2, a class I device, cleared for Biosan Laboratories, Inc. on under FDA product code KEA (Resins, Ion-Exchange). FDA records list 10 510(k) clearances for Biosan Laboratories, Inc., from to . As of , FDA records show no recalls naming K833319.

Clearance record

Decision date
Received
(38 days to decision)
Product code
KEA Resins, Ion-Exchange
Regulation
21 CFR 862.2230
Device class
Class I
Review panel
Clinical Chemistry
Applicant
Biosan Laboratories, Inc. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code KEA

Trailing 12 months

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

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