510(k) K896829

TECHNICON RA SYSTEMS SODIUM (COLORIMETRIC METHOD) by Technicon Instruments Corp. — Product Code JGT

K896829 is an FDA 510(k) premarket notification submitted by Technicon Instruments Corp. for the device "TECHNICON RA SYSTEMS SODIUM (COLORIMETRIC METHOD)". The FDA issued a decision of Substantially Equivalent on February 23, 1990. The device falls under product code JGT (Flame Photometry, Sodium), a Class II device regulated under 21 CFR 862.1665. Technicon Instruments Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 23, 1990
Date Received
December 4, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Flame Photometry, Sodium
Device Class
Class II
Regulation Number
862.1665
Review Panel
CH
Submission Type