510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K984141Substantially Equivalent

Gbact + Kit

Sienco, Inc., Wheatridge CO / Special, Substantially Equivalent
FDA source (opens on fda.gov)

K984141 is the FDA 510(k) clearance record for GBACT + KIT, a class II device, cleared for Sienco, Inc. on under FDA product code JBP (Activated Whole Blood Clotting Time). FDA records list 5 510(k) clearances for Sienco, Inc., from to . As of , FDA records show no recalls naming K984141.

Clearance record

Decision date
Received
(191 days to decision)
Product code
JBP Activated Whole Blood Clotting Time
Regulation
21 CFR 864.7140
Device class
Class II
Review panel
Hematology
Applicant
Sienco, Inc. 4892 Van Gordon St., Unit 203, Wheatridge CO
510(k) summary
Summary
Third party review
No

Clearances, product code JBP

Trailing 12 months

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

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