Ria-Gnost Ferritin
FDA 510(k) K890697 · Cambridge Medical Technology
510(k) numberK890697
Submission
- Device name
- Ria-Gnost Ferritin
- Applicant
- Cambridge Medical Technology
Billerica, MA, US - Received
- February 10, 1989
- Decision date
- March 16, 1989
- 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
Other 510(k)s with product code JMG
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| 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 |
More from Microgenics Corp.
| 510(k) | Device | Decision |
|---|---|---|
| K890837 | Ria-Gnost InsulinCFP · Traditional | 04/26/1989SE |
| K890836 | Ria-Gnost ProgesteroneJLS · Traditional | 03/16/1989SE |
| K873737 | No Spin(Tm) T3 Coated Tube RadioimmunoassayCDP · Traditional | 11/24/1987SE |
| K870573 | T4 No Spin(Tm) Coated Tube Radioimmunoassay KitCDX · Traditional | 04/22/1987SE |
| K862871 | Radioimmunoassay of No Spin(Tm) CortisolCGR · Traditional | 08/19/1986SE |
| K860130 | Testosterone Coated Tubes Radioimmunoassay KitCDZ · Traditional | 02/19/1986SE |
| K855169 | T3 Uptake Radioimmunoassay KitKHQ · Traditional | 02/06/1986SE |
| K850254 | Parathyroid Hormone Radioimmunoassay KitCEW · Traditional | 04/03/1985SE |
| K843635 | Matched Component Set for Radioimmuno-JKC · Traditional | 09/28/1984SE |
| K841042 | Matched Component Set RadioimmunoassayCDZ · Traditional | 04/19/1984SE |
Questions and answers
When was Ria-Gnost Ferritin cleared by the FDA?
Ria-Gnost Ferritin (K890697) received a 510(k) decision of Substantially Equivalent on March 16, 1989, 34 days after the submission was received.
What is the product code of K890697?
The FDA product code is JMG – Radioimmunoassay (Two-Site Solid Phase), Ferritin, a Class II (moderate risk) device regulated under 21 CFR 866.5340.