510(k) K833193

RADIOIMMUNOASSAY, THYROID STIMU. HORMONE by Biosan Laboratories, Inc. — Product Code JLW

K833193 is an FDA 510(k) premarket notification submitted by Biosan Laboratories, Inc. for the device "RADIOIMMUNOASSAY, THYROID STIMU. HORMONE". The FDA issued a decision of Substantially Equivalent on February 4, 1984. The device falls under product code JLW (Radioimmunoassay, Thyroid-Stimulating Hormone), a Class II device regulated under 21 CFR 862.1690. Biosan Laboratories, Inc. has at least 9 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 4, 1984
Date Received
September 19, 1983
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