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
K001891Substantially Equivalent

Microsample Coagulation Analyzer, Model Mca 310-C

Bio/Data Corp., Horsham PA / Special, Substantially Equivalent
FDA source (opens on fda.gov)

K001891 is the FDA 510(k) clearance record for MICROSAMPLE COAGULATION ANALYZER, MODEL MCA 310-C, a class II device, cleared for Bio/Data Corp. on under FDA product code GKP (Instrument, Coagulation, Automated). FDA records list 37 510(k) clearances for Bio/Data Corp., from to . As of , FDA records show no recalls naming K001891.

Clearance record

Decision date
Received
(21 days to decision)
Product code
GKP Instrument, Coagulation, Automated
Regulation
21 CFR 864.5400
Device class
Class II
Review panel
Hematology
Applicant
Bio/Data Corp. 155 Gibraltar Rd., Horsham PA
510(k) summary
Summary
Third party review
No

Clearances, product code GKP

Trailing 12 months

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

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