Blhi Luteinizing Hormone
FDA 510(k) K851332 · Euro-Diagnostics BV
510(k) numberK851332
Submission
- Device name
- Blhi Luteinizing Hormone
- Applicant
- Euro-Diagnostics BV
Old Greenwich, CT, US - Received
- April 4, 1985
- Decision date
- July 9, 1985
- 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 |
More from Selfcare, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K851148 | TSH IRMA(125I) Btsi 1(THYROID Stimula-HormoneJLW · Traditional | 04/29/1985SE |
| K850053 | Baci 6 -Adrenocorticotroop HormoneCKG · Traditional | 04/08/1985SE |
| K843930 | Irma Immunoradiometric Assay-Fsh 125ICGJ · Traditional | 10/30/1984SE |
| K842478 | Prolactin IrmaCFT · Traditional | 09/14/1984SE |
Questions and answers
When was Blhi Luteinizing Hormone cleared by the FDA?
Blhi Luteinizing Hormone (K851332) received a 510(k) decision of Substantially Equivalent on July 9, 1985, 96 days after the submission was received.
What is the product code of K851332?
The FDA product code is CEP – Radioimmunoassay, Luteinizing Hormone, a Class I (low risk) device regulated under 21 CFR 862.1485.