510(k) K771656

PROLACTIN RIA DIAG. KIT by Abbott Laboratories — Product Code JMF

K771656 is an FDA 510(k) premarket notification submitted by Abbott Laboratories for the device "PROLACTIN RIA DIAG. KIT". The FDA issued a decision of Substantially Equivalent on September 22, 1977. The device falls under product code JMF (Radioimmunoassay, Human Placental Lactogen), a Class II device regulated under 21 CFR 862.1585. Abbott Laboratories has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 22, 1977
Date Received
August 29, 1977
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Radioimmunoassay, Human Placental Lactogen
Device Class
Class II
Regulation Number
862.1585
Review Panel
CH
Submission Type