Quantimune HLH Ria Human Lutenizing Horm
FDA 510(k) K810302 · Bio-Rad
510(k) numberK810302
Submission
- Device name
- Quantimune HLH Ria Human Lutenizing Horm
- Applicant
- Bio-Rad
Mchenry, IL, US - Received
- February 5, 1981
- Decision date
- February 25, 1981
- 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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| 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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Questions and answers
When was Quantimune HLH Ria Human Lutenizing Horm cleared by the FDA?
Quantimune HLH Ria Human Lutenizing Horm (K810302) received a 510(k) decision of Substantially Equivalent on February 25, 1981, 20 days after the submission was received.
What is the product code of K810302?
The FDA product code is CEP – Radioimmunoassay, Luteinizing Hormone, a Class I (low risk) device regulated under 21 CFR 862.1485.