510(k) K810948

RADIOIMMUNOASSAY THYROID STIM. HORM. KIT by Endocrine-Metabolic Center — Product Code JLW

K810948 is an FDA 510(k) premarket notification submitted by Endocrine-Metabolic Center for the device "RADIOIMMUNOASSAY THYROID STIM. HORM. KIT". The FDA issued a decision of Substantially Equivalent on April 17, 1981. The device falls under product code JLW (Radioimmunoassay, Thyroid-Stimulating Hormone), a Class II device regulated under 21 CFR 862.1690. Endocrine-Metabolic Center has at least 8 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 17, 1981
Date Received
April 7, 1981
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