510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K903698Substantially Equivalent

Statspin Micro-Hematocrit Reader for 75Mm Tubes

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

K903698 is the FDA 510(k) clearance record for STATSPIN MICRO-HEMATOCRIT READER FOR 75MM TUBES, a class II device, cleared for Statspin Technologies on under FDA product code JPI (Device, Hematocrit Measuring). FDA records list 4 510(k) clearances for Statspin Technologies, from to . As of , FDA records show no recalls naming K903698.

Clearance record

Decision date
Received
(33 days to decision)
Product code
JPI Device, Hematocrit Measuring
Regulation
21 CFR 864.6400
Device class
Class II
Review panel
Hematology
Applicant
Statspin Technologies 85 Morse St., Norwood MA
Third party review
No

Clearances, product code JPI

Trailing 12 months

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

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