Cleared Traditional

FIRST RESPONSE 10 MINUTE OVULATION PREDICTOR TEST

K883530 · Tambrands, Inc. · Chemistry
Dec 1988
Decision
123d
Days
Class 1
Risk

About This 510(k) Submission

K883530 is an FDA 510(k) clearance for the FIRST RESPONSE 10 MINUTE OVULATION PREDICTOR TEST, a Radioimmunoassay, Luteinizing Hormone (Class I — General Controls, product code CEP), submitted by Tambrands, Inc. (Palmer, US). The FDA issued a Cleared decision on December 19, 1988, 123 days after receiving the submission on August 18, 1988. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1485.

Submission Details

510(k) Number K883530 FDA.gov
FDA Decision Cleared SESE
Date Received August 18, 1988
Decision Date December 19, 1988
Days to Decision 123 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary —

Device Classification

Product Code CEP — Radioimmunoassay, Luteinizing Hormone
Device Class Class I — General Controls
CFR Regulation 21 CFR 862.1485

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