510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K002350Substantially Equivalent

Refacto Laboratory Standard

The Genetics Institute, Cambridge MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K002350 is the FDA 510(k) clearance record for REFACTO LABORATORY STANDARD, a class II device, cleared for The Genetics Institute on under FDA product code GGP (Test, Qualitative And Quantitative Factor Deficiency). FDA records list one 510(k) clearance for The Genetics Institute. As of , FDA records show no recalls naming K002350.

Clearance record

Decision date
Received
(64 days to decision)
Product code
GGP Test, Qualitative And Quantitative Factor Deficiency
Regulation
21 CFR 864.7290
Device class
Class II
Review panel
Hematology
Applicant
The Genetics Institute 87 Cambridge Park Dr., Cambridge MA
510(k) summary
Summary
Third party review
No

Clearances, product code GGP

Trailing 12 months

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

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