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
K961814Substantially Equivalent

Thrombolytic Assessment System Prothrombin Time Test Controls

Cardiovascular Diagnostics, Inc., Raleigh NC / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K961814 is the FDA 510(k) clearance record for THROMBOLYTIC ASSESSMENT SYSTEM PROTHROMBIN TIME TEST CONTROLS, a class II device, cleared for Cardiovascular Diagnostics, Inc. on under FDA product code GIZ (Plasma, Control, Normal). FDA records list 13 510(k) clearances for Cardiovascular Diagnostics, Inc., from to . As of , FDA records show no recalls naming K961814.

Clearance record

Decision date
Received
(95 days to decision)
Product code
GIZ Plasma, Control, Normal
Regulation
21 CFR 864.5425
Device class
Class II
Review panel
Hematology
Applicant
Cardiovascular Diagnostics, Inc. 5301 Departure Dr., Raleigh NC
510(k) summary
Summary
Third party review
No

Clearances, product code GIZ

Trailing 12 months

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

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