Cleared Traditional

K863121 - PEAK OVULATION PREDICTOR
(FDA 510(k) Clearance)

K863121 · Micron Technology, Inc. · Toxicology

Oct 1986

Decision

61d

Days

Class 1

Risk

K863121 is an FDA 510(k) clearance for the PEAK OVULATION PREDICTOR, a Test, Luteinizing Hormone (lh), Over The Counter (Class I — General Controls, product code NGE), submitted by Micron Technology, Inc. (Boise, US). The FDA issued a Cleared decision on October 14, 1986, 61 days after receiving the submission on August 14, 1986. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.1485.

Submission Details

510(k) Number	K863121 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 14, 1986
Decision Date	October 14, 1986
Days to Decision	61 days
Submission Type	Traditional
Review Panel	Toxicology (TX)
Summary	—