Dupont Aca Plus Luteinizing Hormone (LH) Method
FDA 510(k) K943996 · Dupont Medical Products
510(k) numberK943996
Submission
- Device name
- Dupont Aca Plus Luteinizing Hormone (LH) Method
- Applicant
- Dupont Medical Products
N. Billerica, MA, US - Received
- August 16, 1994
- Decision date
- October 20, 1994
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K013582 | Maybe?Mom Mini Ovulation MicroscopeCEP · Traditional | Maybe?Mom | 01/16/2003SE |
| K022829 | Instant-View LH Ovulation Predicting TestCEP · Abbreviated | Alfa Scientific Designs, Inc. | 11/05/2002SE |
| K021409 | At Home Ovulation Test, Model 9032CEP · Special | Phamatech, Inc. | 05/24/2002SE |
| K013874 | Clearplane Easy Ovulation TestCEP · Traditional | Unipath , Ltd. | 02/19/2002SE |
| K013323 | TCI-31 Lifelong Ovulation TesterCEP · Traditional | Tci New York | 12/05/2001SE |
| 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 |
More from Selfcare, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K952815 | Dupont Lipase CalibratorJIT · Traditional | 08/31/1995SE |
| K950920 | Dupont Dimension Total Protein MethodCEK · Traditional | 08/11/1995SE |
| K952816 | Lipase Flex Reagent CartridgeCHI · Traditional | 07/20/1995SE |
| K952412 | Dupont Aca(R) Urine Druge Os Abuse ControlDIF · Traditional | 06/23/1995SE |
| K945280 | Dupont Dimension C-Reactive Protein MethodDCK · Traditional | 03/09/1995SE |
| K944932 | Phenobarbital Flex Reagent CartridgeDLZ · Traditional | 12/28/1994SE |
| K941050 | Dupont Aca StarJJQ · Traditional | 11/10/1994SE |
| K941146 | Dupont Aca Plus Thyroid Stimulating Hormone SystemJLW · Traditional | 10/03/1994SE |
| K942640 | Dupont Dimension Amylase MethodJFJ · Traditional | 09/09/1994SE |
| K942241 | Dupont Apc Blood Collection Container with ThromboplastinJKA · Traditional | 08/18/1994SE |
Questions and answers
When was Dupont Aca Plus Luteinizing Hormone (LH) Method cleared by the FDA?
Dupont Aca Plus Luteinizing Hormone (LH) Method (K943996) received a 510(k) decision of Substantially Equivalent on October 20, 1994, 65 days after the submission was received.
What is the product code of K943996?
The FDA product code is CEP – Radioimmunoassay, Luteinizing Hormone, a Class I (low risk) device regulated under 21 CFR 862.1485.