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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Test, Luteinizing Hormone (Lh), Over The Counter
510(k) Number K863121
Device Name PEAK OVULATION PREDICTOR
Applicant
Micron Technology, Inc.
2805 E. Columbia Rd.
Boise,  ID  83706
Applicant Contact KIPP BEDARD
Correspondent
Micron Technology, Inc.
2805 E. Columbia Rd.
Boise,  ID  83706
Correspondent Contact KIPP BEDARD
Regulation Number862.1485
Classification Product Code
NGE  
Date Received08/14/1986
Decision Date 10/14/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Toxicology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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