510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K870860Substantially Equivalent

Chempro 1000(Tm)

Arden Medical Systems, Inc., Arden Hills MN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K870860 is the FDA 510(k) clearance record for CHEMPRO 1000(TM), a class II device, cleared for Arden Medical Systems, Inc. on under FDA product code GKF (Instrument, Hematocrit, Automated). FDA records list 3 510(k) clearances for Arden Medical Systems, Inc., from to . As of , FDA records show no recalls naming K870860.

Clearance record

Decision date
Received
(42 days to decision)
Product code
GKF Instrument, Hematocrit, Automated
Regulation
21 CFR 864.5600
Device class
Class II
Review panel
Hematology
Applicant
Arden Medical Systems, Inc. 3771 Lexington Ave. N., Arden Hills MN
Third party review
No

Clearances, product code GKF

Trailing 12 months

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

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