510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K984216Substantially Equivalent

Immuno-Trol Control Cells

Coulter Corp., Miami FL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K984216 is the FDA 510(k) clearance record for IMMUNO-TROL CONTROL CELLS, a class II device, cleared for Coulter Corp. on under FDA product code JPK (Mixture, Hematology Quality Control). FDA records list 51 510(k) clearances for Coulter Corp., from to . As of , FDA records show no recalls naming K984216.

Clearance record

Decision date
Received
(112 days to decision)
Product code
JPK Mixture, Hematology Quality Control
Regulation
21 CFR 864.8625
Device class
Class II
Review panel
Hematology
Applicant
Coulter Corp. 11800 SW 147th Ave., Miami FL
510(k) summary
Summary
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