510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K854260Substantially Equivalent

Chempro 1000

Sen Tech Medical Corp., Arden Hills MN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K854260 is the FDA 510(k) clearance record for CHEMPRO 1000, a class II device, cleared for Sen Tech Medical Corp. on under FDA product code CGA (Glucose Oxidase, Glucose). FDA records list 5 510(k) clearances for Sen Tech Medical Corp., from to . As of , FDA records show no recalls naming K854260.

Clearance record

Decision date
Received
(27 days to decision)
Product code
CGA Glucose Oxidase, Glucose
Regulation
21 CFR 862.1345
Device class
Class II
Review panel
Clinical Chemistry
Applicant
Sen Tech Medical Corp. 3771 Lexington Ave., Arden Hills MN
Third party review
No

Clearances, product code CGA

Trailing 12 months
1 clearance under product code CGA in the twelve months to October 2026, May 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code CGA, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20261
June 20260
July 20260
August 20260
September 20260
October 20260