Opus Ferritin Test System
FDA 510(k) K915838 · Pb Diagnostic Systems, Inc.
510(k) numberK915838
Submission
- Device name
- Opus Ferritin Test System
- Applicant
- Pb Diagnostic Systems, Inc.
Westwood, MA, US - Received
- December 24, 1991
- Decision date
- March 18, 1992
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- DGE – Igd, Rhodamine, Antigen, Antiserum, Control
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.5510
- Specialty
- Immunology
Other 510(k)s with product code DGE
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K871972 | Stratus Ige Fluorometric Enzyme ImmunoassayDGE · Traditional | American Dade | 07/21/1987SE |
More from American Dade
| 510(k) | Device | Decision |
|---|---|---|
| K940507 | Opus FT4 Test SystemCEC · Traditional | 07/28/1994SE |
| K934762 | Opus Procainamide Test SystemLAR · Traditional | 07/20/1994SE |
| K933389 | Opus Cmv-GLFZ · Traditional | 06/28/1994SE |
| K934137 | Opus(R) Serology Controls, ModificationMJX · Traditional | 03/07/1994SE |
| K935229 | Opus DigitoxinDPG · Traditional | 12/22/1993SE |
| K934705 | Opus NapaLAN · Traditional | 11/22/1993SE |
| K933675 | Opus Total CKCGS · Traditional | 09/08/1993SE |
| K933066 | Opus EstradiolCHP · Traditional | 09/08/1993SE |
| K932279 | Opus(R) Total B-Hcg Test SystemJHI · Traditional | 07/08/1993SE |
| K926131 | Opus Magnum AnalyzerKHO · Traditional | 06/07/1993SE |
Questions and answers
When was Opus Ferritin Test System cleared by the FDA?
Opus Ferritin Test System (K915838) received a 510(k) decision of Substantially Equivalent on March 18, 1992, 85 days after the submission was received.
What is the product code of K915838?
The FDA product code is DGE – Igd, Rhodamine, Antigen, Antiserum, Control, a Class II (moderate risk) device regulated under 21 CFR 866.5510.