510(k) K892929

TECHNICON AXON TM SYSTEM ADDITIONAL ANALYTES by Technicon Instruments Corp. — Product Code CHJ

K892929 is an FDA 510(k) premarket notification submitted by Technicon Instruments Corp. for the device "TECHNICON AXON TM SYSTEM ADDITIONAL ANALYTES". The FDA issued a decision of Substantially Equivalent on July 20, 1989. The device falls under product code CHJ (Mercuric Thiocyanate, Colorimetry, Chloride), a Class II device regulated under 21 CFR 862.1170. Technicon Instruments Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 20, 1989
Date Received
April 21, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Mercuric Thiocyanate, Colorimetry, Chloride
Device Class
Class II
Regulation Number
862.1170
Review Panel
CH
Submission Type