510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K020840Substantially Equivalent

Vital Scientific Pt with Calcium

VitalScientific, Newton MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K020840 is the FDA 510(k) clearance record for VITAL SCIENTIFIC PT WITH CALCIUM, a class II device, cleared for Vital Scientific N.V. on under FDA product code GJS (Test, Time, Prothrombin). FDA records list 11 510(k) clearances for VitalScientific, from to . As of , FDA records show no recalls naming K020840.

Clearance record

Decision date
Received
(61 days to decision)
Product code
GJS Test, Time, Prothrombin
Regulation
21 CFR 864.7750
Device class
Class II
Review panel
Hematology
Applicant
Vital Scientific N.V. One Gateway Center, Newton MA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code GJS

Trailing 12 months

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

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