510(k) K771590

THYROID STIMULATING HORMONE by New England Nuclear — Product Code JLW

K771590 is an FDA 510(k) premarket notification submitted by New England Nuclear for the device "THYROID STIMULATING HORMONE". The FDA issued a decision of Substantially Equivalent on September 15, 1977. The device falls under product code JLW (Radioimmunoassay, Thyroid-Stimulating Hormone), a Class II device regulated under 21 CFR 862.1690. New England Nuclear has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 15, 1977
Date Received
August 19, 1977
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