510(k) K860830

TECHNICON H.1 SYSTEM, T LYMPHOCYTES METHOD by Technicon Instruments Corp. — Product Code LIZ

K860830 is an FDA 510(k) premarket notification submitted by Technicon Instruments Corp. for the device "TECHNICON H.1 SYSTEM, T LYMPHOCYTES METHOD". The FDA issued a decision of SN on September 8, 1986. The device falls under product code LIZ (Assay, T Lymphocyte Surface Marker), a Class II device regulated under 21 CFR 864.5220. Technicon Instruments Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SN ()
Decision Date
September 8, 1986
Date Received
March 5, 1986
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Assay, T Lymphocyte Surface Marker
Device Class
Class II
Regulation Number
864.5220
Review Panel
IM
Submission Type