Ovugen Suretest
FDA 510(k) K873534 · Biogenex Laboratories
510(k) numberK873534
Submission
- Device name
- Ovugen Suretest
- Applicant
- Biogenex Laboratories
Dublin, CA, US - Received
- September 1, 1987
- Decision date
- November 23, 1987
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- CEP – Radioimmunoassay, Luteinizing Hormone
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.1485
- Specialty
- Clinical Chemistry
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| K012252 | Quik-Check Ovulation PredictorCEP · Traditional | ACON Laboratories, Inc. | 08/24/2001SE |
| K010244 | Sure Check Ovulation PredictorCEP · Traditional | Chembio Diagnostic Systems, Inc. | 05/02/2001SE |
| K002867 | Inverness Medical Ovulation Predictor TestCEP · Special | Selfcare, Inc. | 10/12/2000SE |
| K991466 | Early Ovulation Predictor (Cassette), One Step Ovulation Predictor (Cassette), Ovulation…CEP · Traditional | Selfcare, Inc. | 05/25/1999SE |
| K991386 | Early Ovulation Predictor (Stick), One Step Ovulation Predictor (Stick), Ovulation…CEP · Traditional | Selfcare, Inc. | 05/25/1999SE |
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| K925189 | Pregnagen 1-STEP Pregnancy TestLCX · Traditional | 01/06/1993SE |
| K902208 | Modified OvugenCEP · Traditional | 07/17/1990SE |
| K884880 | Pregnagen(Tm)JHI · Traditional | 01/13/1989SE |
| K882002 | Pregnagen(Tm)JHI · Traditional | 09/09/1988SE |
| K831221 | Riagen B-Hcg Ria KitJHI · Traditional | 06/02/1983SE |
| K821657 | Riagen B-Hcg RiaJHI · Traditional | 07/13/1982SE |
| K821234 | Riagen B-Hcg RiaJHI · Traditional | 05/21/1982SE |
| K820724 | Fluorogen Pap FiaJFH · Traditional | 04/14/1982SE |
Questions and answers
When was Ovugen Suretest cleared by the FDA?
Ovugen Suretest (K873534) received a 510(k) decision of Substantially Equivalent on November 23, 1987, 83 days after the submission was received.
What is the product code of K873534?
The FDA product code is CEP – Radioimmunoassay, Luteinizing Hormone, a Class I (low risk) device regulated under 21 CFR 862.1485.