510(k) K863121

PEAK OVULATION PREDICTOR by Micron Technology, Inc. — Product Code NGE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 14, 1986
Date Received
August 14, 1986
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Test, Luteinizing Hormone (Lh), Over The Counter
Device Class
Class I
Regulation Number
862.1485
Review Panel
TX
Submission Type