FSH Irma Immunomag
FDA 510(k) K912804 · Pantex, Div. Bio-Analysis, Inc.
510(k) numberK912804
Submission
- Device name
- FSH Irma Immunomag
- Applicant
- Pantex, Div. Bio-Analysis, Inc.
Santa Monica, CA, US - Received
- June 25, 1991
- Decision date
- August 12, 1991
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- CGJ – Radioimmunoassay, Follicle-Stimulating Hormone
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.1300
- Specialty
- Clinical Chemistry
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| 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 |
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Questions and answers
When was FSH Irma Immunomag cleared by the FDA?
FSH Irma Immunomag (K912804) received a 510(k) decision of Substantially Equivalent on August 12, 1991, 48 days after the submission was received.
What is the product code of K912804?
The FDA product code is CGJ – Radioimmunoassay, Follicle-Stimulating Hormone, a Class I (low risk) device regulated under 21 CFR 862.1300.