510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K070005Substantially Equivalent

Hemosil Recombiplastin 2G

Instrumentation Laboratory Co., Bedford MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K070005 is the FDA 510(k) clearance record for HEMOSIL RECOMBIPLASTIN 2G, a class II device, cleared for Instrumentation Laboratory CO on under FDA product code GJS (Test, Time, Prothrombin). FDA records list 327 510(k) clearances for Instrumentation Laboratory CO, from to . As of , FDA records show one recall naming K070005.

Clearance record

Decision date
Received
(224 days to decision)
Product code
GJS Test, Time, Prothrombin
Regulation
21 CFR 864.7750
Device class
Class II
Review panel
Hematology
Applicant
Instrumentation Laboratory CO 180 Hartwell Rd., Bedford 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