Sealite Science, Inc. Aqualite(R) LH
FDA 510(k) K943188 · Sealite Sciences, Inc.
510(k) numberK943188
Submission
- Device name
- Sealite Science, Inc. Aqualite(R) LH
- Applicant
- Sealite Sciences, Inc.
Bogart, GA, US - Received
- July 5, 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
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|---|---|---|---|
| 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 |
|---|---|---|
| K974551 | Sealite Sciences, Inc. Aqualite Free T, AssayCEC · Traditional | 12/22/1997SE |
| K972761 | Sealite Sciences, Inc. Aqualite Human Growth Hormone AssayCFL · Traditional | 09/25/1997SE |
| K970612 | Sealite Sciences, Inc. Aqualite Ferritin AssayDBF · Traditional | 06/24/1997SE |
| K970483 | Aqualite Intact PTHCEW · Traditional | 04/14/1997SE |
| K970188 | Sealite Sciences, Inc. Aqualite ProlactinCFT · Traditional | 02/20/1997SE |
| K970085 | Sealite Sciences Aqualite FSHCGJ · Traditional | 02/14/1997SE |
| K964925 | Sealite Sciences, Inc. Aqualite LHCEP · Traditional | 01/22/1997SE |
| K942661 | Aqualite TSH Bioluminescent Immunoassay KitJLW · Traditional | 01/17/1995SE |
| K943437 | Aqualite FSHCGJ · Traditional | 12/28/1994SE |
| K941983 | Sealite Sciences Inc.DHA · Traditional | 08/18/1994SE |
Questions and answers
When was Sealite Science, Inc. Aqualite(R) LH cleared by the FDA?
Sealite Science, Inc. Aqualite(R) LH (K943188) received a 510(k) decision of Substantially Equivalent on October 20, 1994, 107 days after the submission was received.
What is the product code of K943188?
The FDA product code is CEP – Radioimmunoassay, Luteinizing Hormone, a Class I (low risk) device regulated under 21 CFR 862.1485.