510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K173202Substantially Equivalent

CP3000 Coagulation analyzer, Coagpia AT Reagent, Coagpia Calibrator, Coagpia Control Set

Sekisui Medical Co., Ltd., Chuo-Ku, JP / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K173202 is the FDA 510(k) clearance record for CP3000 Coagulation analyzer, Coagpia AT Reagent, Coagpia Calibrator, Coagpia Control Set, a class II device, cleared for Sekisui Medical Co., Ltd. on under FDA product code JPA (System, Multipurpose For In Vitro Coagulation Studies). FDA records list one 510(k) clearance for Sekisui Medical Co., Ltd. As of , FDA records show no recalls naming K173202.

Clearance record

Decision date
Received
(219 days to decision)
Product code
JPA System, Multipurpose For In Vitro Coagulation Studies
Regulation
21 CFR 864.5425
Device class
Class II
Review panel
Hematology
Applicant
Sekisui Medical Co., Ltd. 1-3 Nihonbashi 2-Chome, Chuo-Ku, JP
510(k) summary
Summary PDF
Third party review
No

Clearances, product code JPA

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