510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K823794Substantially Equivalent

Control Tm 8

General Diagnostics, Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K823794 is the FDA 510(k) clearance record for CONTROL TM 8, a class II device, cleared for General Diagnostics on under FDA product code GLQ (Mixture, Control, White-Cell And Red-Cell Indices). FDA records list 39 510(k) clearances for General Diagnostics, from to . As of , FDA records show no recalls naming K823794.

Clearance record

Decision date
Received
(29 days to decision)
Product code
GLQ Mixture, Control, White-Cell And Red-Cell Indices
Regulation
21 CFR 864.8625
Device class
Class II
Review panel
Hematology
Applicant
General Diagnostics 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code GLQ

Trailing 12 months

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

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