Simultaneous Lh/Fsh System by Ria

FDA 510(k) K852376 · American Bioclinical, Inc.

Substantially Equivalent

510(k) numberK852376

Submission

Device name
Simultaneous Lh/Fsh System by Ria
Applicant
American Bioclinical, Inc.
Portland, OR, US
Received
June 4, 1985
Decision date
July 9, 1985
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
CEP – Radioimmunoassay, Luteinizing Hormone
Device class
Class I (low risk)
Regulation
21 CFR 862.1485
Specialty
Clinical Chemistry

Other 510(k)s with product code CEP

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K013582Maybe?Mom Mini Ovulation MicroscopeCEP · Traditional Maybe?Mom01/16/2003SE
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K021409At Home Ovulation Test, Model 9032CEP · Special Phamatech, Inc.05/24/2002SE
K013874Clearplane Easy Ovulation TestCEP · Traditional Unipath , Ltd.02/19/2002SE
K013323TCI-31 Lifelong Ovulation TesterCEP · Traditional Tci New York12/05/2001SE
K012252Quik-Check Ovulation PredictorCEP · Traditional ACON Laboratories, Inc.08/24/2001SE
K010244Sure Check Ovulation PredictorCEP · Traditional Chembio Diagnostic Systems, Inc.05/02/2001SE
K002867Inverness Medical Ovulation Predictor TestCEP · Special Selfcare, Inc.10/12/2000SE
K991466Early Ovulation Predictor (Cassette), One Step Ovulation Predictor (Cassette), Ovulation…CEP · Traditional Selfcare, Inc.05/25/1999SE
K991386Early Ovulation Predictor (Stick), One Step Ovulation Predictor (Stick), Ovulation…CEP · Traditional Selfcare, Inc.05/25/1999SE

More from Selfcare, Inc.

510(k)DeviceDecision
K852939Cortisol System by EiaCGR · Traditional 08/02/1985SE
K852437Visual Serum/Urine HCG Combo KitJHI · Traditional 07/12/1985SE
K851330Prolactin System by RiaCFT · Traditional 04/29/1985SE

Questions and answers

When was Simultaneous Lh/Fsh System by Ria cleared by the FDA?

Simultaneous Lh/Fsh System by Ria (K852376) received a 510(k) decision of Substantially Equivalent on July 9, 1985, 35 days after the submission was received.

What is the product code of K852376?

The FDA product code is CEP – Radioimmunoassay, Luteinizing Hormone, a Class I (low risk) device regulated under 21 CFR 862.1485.