510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K833708Substantially Equivalent

Compur* M1000 Hemoglobin & Erythrocyte

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

K833708 is the FDA 510(k) clearance record for COMPUR* M1000 HEMOGLOBIN & ERYTHROCYTE, a class II device, cleared for Worthington Diagnostic Systems on under FDA product code LKZ (Red-Cell Count By Photometry). FDA records list 19 510(k) clearances for Worthington Diagnostic Systems, from to . As of , FDA records show no recalls naming K833708.

Clearance record

Decision date
Received
(76 days to decision)
Product code
LKZ Red-Cell Count By Photometry
Regulation
21 CFR 864.7100
Device class
Class II
Review panel
Hematology
Applicant
Worthington Diagnostic Systems 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code LKZ

Trailing 12 months

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

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