Quantimune Ferritin Irma
FDA 510(k) K810799 · Bio-Rad
510(k) numberK810799
Submission
- Device name
- Quantimune Ferritin Irma
- Applicant
- Bio-Rad
Mchenry, IL, US - Received
- March 23, 1981
- Decision date
- April 3, 1981
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- JMG – Radioimmunoassay (Two-Site Solid Phase), Ferritin
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.5340
- Specialty
- Immunology
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|---|---|---|---|
| K234052 | Access FerritinJMG · Traditional | Beckman Coulter, Inc. | 03/20/2024SE |
| K052082 | Ferritin on the Access Immunoassay Systems, Model 33020JMG · Special | Beckman Coulter, Inc. | 08/19/2005SE |
| K964282 | Tina-Quant Ferritin AssayJMG · Traditional | Boehringer Mannheim Corp. | 07/30/1997SE |
| K971833 | Elecsys FerritinJMG · Traditional | Boehringer Mannheim Corp. | 06/02/1997SE |
| K963498 | Ferr Flex Reagent CartridgeJMG · Traditional | Dade Chemistry Systems, Inc. | 01/24/1997SE |
| K950393 | Ace(Tm) Cedia(R) Ferritin AssayJMG · Traditional | Schiapparelli Biosystems, Inc. | 05/16/1995SE |
| K926221 | Access Ferritin AssayJMG · Traditional | Bio-Rad Laboratories, Inc. | 01/13/1993SE |
| K925848 | Immulite FerritinJMG · Traditional | Diagnostic Products Corp. | 01/13/1993SE |
| K920829 | Cobas Core Ferritin EiaJMG · Traditional | Roche Diagnostic Systems, Inc. | 06/19/1992SE |
| K920318 | Cedia Ferritin AssayJMG · Traditional | Microgenics Corp. | 06/04/1992SE |
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Questions and answers
When was Quantimune Ferritin Irma cleared by the FDA?
Quantimune Ferritin Irma (K810799) received a 510(k) decision of Substantially Equivalent on April 3, 1981, 11 days after the submission was received.
What is the product code of K810799?
The FDA product code is JMG – Radioimmunoassay (Two-Site Solid Phase), Ferritin, a Class II (moderate risk) device regulated under 21 CFR 866.5340.