510(k) K842110

SLIDE PREGNANCY TEST by Immunostics Co., Inc. — Product Code JHJ

K842110 is an FDA 510(k) premarket notification submitted by Immunostics Co., Inc. for the device "SLIDE PREGNANCY TEST". The FDA issued a decision of Substantially Equivalent on July 12, 1984. The device falls under product code JHJ (Agglutination Method, Human Chorionic Gonadotropin), a Class II device regulated under 21 CFR 862.1155. Immunostics Co., Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 12, 1984
Date Received
May 29, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Agglutination Method, Human Chorionic Gonadotropin
Device Class
Class II
Regulation Number
862.1155
Review Panel
CH
Submission Type