LH Irma Immunomag
FDA 510(k) K911050 · Pantex, Div. Bio-Analysis, Inc.
510(k) numberK911050
Submission
- Device name
- LH Irma Immunomag
- Applicant
- Pantex, Div. Bio-Analysis, Inc.
Santa Monica, CA, US - Received
- March 8, 1991
- Decision date
- April 12, 1991
- 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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| 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.
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|---|---|---|
| K102841 | Pantex Am/Pm Salivary Cortisol Enzyme ImmunoassayNHG · Traditional | 05/08/2012SE |
| K942658 | Neoscreen Elisa TSHJLW · Traditional | 02/24/1995SE |
| K914107 | Prolactin Irma ImmunomagCFT · Traditional | 09/30/1991SE |
| K912804 | FSH Irma ImmunomagCGJ · Traditional | 08/12/1991SE |
| K911839 | Neonatal Blood Spot Test 17-HYDROXPROG Radio KitJLX · Traditional | 06/18/1991SE |
| K910717 | Pantex Irma LH 1251 KitCEP · Traditional | 03/19/1991SE |
| K894049 | Immunocoat Progesterone Radioimmunoassay KitJLS · Traditional | 09/08/1989SE |
| K862483 | Pantex Fte Free Testosterone Radioimmunoassay KitCDZ · Traditional | 01/14/1987SE |
| K862447 | Pancoat T3 Uptake Coated Tube Radioimmunoassay KitKHQ · Traditional | 10/07/1986SE |
| K862336 | Pancoat Cortisol Coated Tube Radioimmunoassay KitCGR · Traditional | 09/25/1986SE |
Questions and answers
When was LH Irma Immunomag cleared by the FDA?
LH Irma Immunomag (K911050) received a 510(k) decision of Substantially Equivalent on April 12, 1991, 35 days after the submission was received.
What is the product code of K911050?
The FDA product code is CEP – Radioimmunoassay, Luteinizing Hormone, a Class I (low risk) device regulated under 21 CFR 862.1485.