510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K894425Substantially Equivalent

Acs Human Plasma Coagulation Control Level III

Analytical Control Systems, Indianapolis IN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K894425 is the FDA 510(k) clearance record for ACS HUMAN PLASMA COAGULATION CONTROL LEVEL III, a class II device, cleared for Analytical Control Systems, Inc. on under FDA product code GGC (Control, Plasma, Abnormal). FDA records list 42 510(k) clearances for Analytical Control Systems, Inc., from to . As of , FDA records show no recalls naming K894425.

Clearance record

Decision date
Received
(17 days to decision)
Product code
GGC Control, Plasma, Abnormal
Regulation
21 CFR 864.5425
Device class
Class II
Review panel
Hematology
Applicant
Analytical Control Systems, Inc. 155 E. Market, Suite 502, Indianapolis IN
Third party review
No

Clearances, product code GGC

Trailing 12 months

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

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