510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K852516Substantially Equivalent

Centifuge, Hematocrit & Microsedimentation Combine

Whittaker General Medical, Richmond VA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K852516 is the FDA 510(k) clearance record for CENTIFUGE, HEMATOCRIT & MICROSEDIMENTATION COMBINE, a class II device, cleared for Whittaker General Medical on under FDA product code JPI (Device, Hematocrit Measuring). FDA records list one 510(k) clearance for Whittaker General Medical. As of , FDA records show no recalls naming K852516.

Clearance record

Decision date
Received
(32 days to decision)
Product code
JPI Device, Hematocrit Measuring
Regulation
21 CFR 864.6400
Device class
Class II
Review panel
Hematology
Applicant
Whittaker General Medical 8741 Landmark Rd., Richmond VA
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