510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K844897Substantially Equivalent

Hematology Control Uni-Cell 5, Uni-Cell 7 & 8

Medical Specialties Laboratories, Boston MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K844897 is the FDA 510(k) clearance record for HEMATOLOGY CONTROL UNI-CELL 5, UNI-CELL 7 & 8, a class II device, cleared for Medical Specialties Laboratories on under FDA product code JPK (Mixture, Hematology Quality Control). FDA records list 5 510(k) clearances for Medical Specialties Laboratories, from to . As of , FDA records show no recalls naming K844897.

Clearance record

Decision date
Received
(95 days to decision)
Product code
JPK Mixture, Hematology Quality Control
Regulation
21 CFR 864.8625
Device class
Class II
Review panel
Hematology
Applicant
Medical Specialties Laboratories P.O.Box 659, Kenmore Station, Boston MA
Third party review
No

Clearances, product code JPK

Trailing 12 months

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

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