510(k) K781150

RIA TSH IN HUMAN SERUM OR PLASMA by Diagnostic Corp. of America — Product Code JLW

K781150 is an FDA 510(k) premarket notification submitted by Diagnostic Corp. of America for the device "RIA TSH IN HUMAN SERUM OR PLASMA". The FDA issued a decision of Substantially Equivalent on July 27, 1978. The device falls under product code JLW (Radioimmunoassay, Thyroid-Stimulating Hormone), a Class II device regulated under 21 CFR 862.1690. Diagnostic Corp. of America has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 27, 1978
Date Received
July 10, 1978
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