510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K920759Substantially Equivalent

Critspin Micro-Hematocrit

Stat-Spin Technologies, Norwood MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K920759 is the FDA 510(k) clearance record for CRITSPIN MICRO-HEMATOCRIT, a class II device, cleared for Stat-Spin Technologies on under FDA product code GKG (Centrifuge, Hematocrit). FDA records list one 510(k) clearance for Stat-Spin Technologies. As of , FDA records show no recalls naming K920759.

Clearance record

Decision date
Received
(70 days to decision)
Product code
GKG Centrifuge, Hematocrit
Regulation
21 CFR 864.6400
Device class
Class II
Review panel
Hematology
Applicant
Stat-Spin Technologies 85 Morse St., Norwood MA
510(k) summary
Summary
Third party review
No

Clearances, product code GKG

Trailing 12 months

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

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