510(k) K861918

V-TREND EIA TSH by V-Tech, Inc. — Product Code JLW

K861918 is an FDA 510(k) premarket notification submitted by V-Tech, Inc. for the device "V-TREND EIA TSH". The FDA issued a decision of Substantially Equivalent on July 2, 1986. The device falls under product code JLW (Radioimmunoassay, Thyroid-Stimulating Hormone), a Class II device regulated under 21 CFR 862.1690. V-Tech, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 2, 1986
Date Received
May 19, 1986
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Radioimmunoassay, Thyroid-Stimulating Hormone
Device Class
Class II
Regulation Number
862.1690
Review Panel
CH
Submission Type