510(k) K822935

THYROID STIMULATING HORMONE by Pcl-Ria, Inc. — Product Code JLW

K822935 is an FDA 510(k) premarket notification submitted by Pcl-Ria, Inc. for the device "THYROID STIMULATING HORMONE". The FDA issued a decision of Substantially Equivalent on November 1, 1982. The device falls under product code JLW (Radioimmunoassay, Thyroid-Stimulating Hormone), a Class II device regulated under 21 CFR 862.1690. Pcl-Ria, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 1, 1982
Date Received
October 4, 1982
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