Cleared Traditional

K973310 - TBD* ONE-STEP OVULATION PREDICTOR TEST
(FDA 510(k) Clearance)

K973310 · Armkel, LLC · Chemistry

Oct 1997

Decision

54d

Days

Class 1

Risk

K973310 is an FDA 510(k) clearance for the TBD* ONE-STEP OVULATION PREDICTOR TEST, a Radioimmunoassay, Luteinizing Hormone (Class I — General Controls, product code CEP), submitted by Armkel, LLC (Cranbury, US). The FDA issued a Cleared decision on October 27, 1997, 54 days after receiving the submission on September 3, 1997. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1485.

Submission Details

510(k) Number	K973310 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 03, 1997
Decision Date	October 27, 1997
Days to Decision	54 days
Submission Type	Traditional
Review Panel	Chemistry (CH)
Summary	Summary PDF