510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K820401Substantially Equivalent

Ortho* Hematology Contr. 8 Abn. Hi/low

Orhto Diagnostic Systems, Inc., Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K820401 is the FDA 510(k) clearance record for ORTHO* HEMATOLOGY CONTR. 8 ABN. HI/LOW, a class II device, cleared for Orhto Diagnostic Systems, Inc. on under FDA product code JPK (Mixture, Hematology Quality Control). FDA records list one 510(k) clearance for Orhto Diagnostic Systems, Inc. As of , FDA records show no recalls naming K820401.

Clearance record

Decision date
Received
(31 days to decision)
Product code
JPK Mixture, Hematology Quality Control
Regulation
21 CFR 864.8625
Device class
Class II
Review panel
Hematology
Applicant
Orhto Diagnostic Systems, Inc. 803 N. Front St. Suite 3, Mchenry IL
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