510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K810899Substantially Equivalent

Technicon Autogrouper 16-C System

Technicon Instruments Corp., Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K810899 is the FDA 510(k) clearance record for TECHNICON AUTOGROUPER 16-C SYSTEM, a class II device, cleared for Technicon Instruments Corp. on under FDA product code KSZ (System, Test, Automated Blood Grouping And Antibody). FDA records list 157 510(k) clearances for Technicon Instruments Corp., from to . As of , FDA records show no recalls naming K810899.

Clearance record

Decision date
Received
(32 days to decision)
Product code
KSZ System, Test, Automated Blood Grouping And Antibody
Regulation
21 CFR 864.9175
Device class
Class II
Review panel
Hematology
Applicant
Technicon Instruments Corp. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code KSZ

Trailing 12 months

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

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