Radioimmunoassay Luteinizing Hormone
FDA 510(k) K811994 · Endocrine-Metabolic Center
510(k) numberK811994
Submission
- Device name
- Radioimmunoassay Luteinizing Hormone
- Applicant
- Endocrine-Metabolic Center
Mchenry, IL, US - Received
- July 14, 1981
- Decision date
- July 27, 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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| 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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|---|---|---|
| K821131 | Radioimmunoassay Parathyroid Hormone MidCEW · Traditional | 06/02/1982SE |
| K811993 | Radioimmunoassay, Follicle StimulatingCGJ · Traditional | 08/03/1981SE |
| K810948 | Radioimmunoassay Thyroid Stim. Horm. KitJLW · Traditional | 04/17/1981SE |
| K810351 | Radioimmunoassay, Total TriiodothronieCDP · Traditional | 02/23/1981SE |
| K800188 | EMC-M-180, T3 Uptake - 100 TubesKHQ · Traditional | 02/13/1980SE |
| K800187 | EMC-M-175, Thyroxine - 100 TubesCDX · Traditional | 02/13/1980SE |
| K790602 | Ria, DIGNXIN-125-IDPB · Traditional | 07/30/1979SE |
| K790630 | Ria, Insulin, Double AntibodyCFP · Traditional | 07/24/1979SE |
Questions and answers
When was Radioimmunoassay Luteinizing Hormone cleared by the FDA?
Radioimmunoassay Luteinizing Hormone (K811994) received a 510(k) decision of Substantially Equivalent on July 27, 1981, 13 days after the submission was received.
What is the product code of K811994?
The FDA product code is CEP – Radioimmunoassay, Luteinizing Hormone, a Class I (low risk) device regulated under 21 CFR 862.1485.