Epo-Ria
FDA 510(k) K910481 · Ramco Laboratories, Inc.
510(k) numberK910481
Submission
- Device name
- Epo-Ria
- Applicant
- Ramco Laboratories, Inc.
Houston, TX, US - Received
- February 6, 1991
- Decision date
- November 29, 1991
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- GGT – Assay, Erythropoietin
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 864.7250
- Specialty
- Hematology
Other 510(k)s with product code GGT
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K240182 | Access EPOGGT · Traditional | Beckman Coulter, Inc. | 04/22/2024SE |
| K183088 | ADVIA Centaur Erythropoietin (EPO) assayGGT · Traditional | Axis-Shield Diagnostics Limited | 08/02/2019SE |
| K052223 | Access Epo AssayGGT · Abbreviated | Beckman Coulter, Inc. | 10/06/2006SE |
| K992799 | Sangui Biotech, Inc. Epo (Erythropoietin) Elisa KitGGT · Traditional | Sangui Biotech, Inc. | 06/07/2000SE |
| K983203 | Immulite Epo, Model #'S Lkepz & LKEP1GGT · Traditional | Diagnostic Products Corp. | 07/12/1999SE |
| K980737 | Advantage Chemiluminescence Erythropoietin ImmunoassayGGT · Traditional | Nichols Institute Diagnostics | 03/23/1999SE |
| K952559 | Erythropoietin Immunoassay KitGGT · Traditional | Nichols Institute | 05/29/1996SE |
| K954898 | Predicta Erythropoietin Kit (Modification)GGT · Traditional | Genzyme Corp. | 02/05/1996SE |
| K936016 | Quantikine IVD Erythropoietin Enzyme Linked Immunosorbent Assay (Elisa)GGT · Traditional | R&D Systems, Inc. | 07/19/1994SE |
| K931756 | Quantikine(Tm) Erythropoietin Human Serum ControlsGGT · Traditional | R&D Systems, Inc. | 04/21/1994SE |
More from R&D Systems, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K983107 | VfeGGP · Traditional | 10/22/1998SE |
| K981208 | TFRJNM · Traditional | 10/21/1998SE |
| K872941 | Spectro CGGP · Traditional | 09/04/1987SE |
| K864701 | VWF ImmunoblotGGP · Traditional | 03/30/1987SE |
| K861159 | Spectro VWFGGP · Traditional | 05/01/1986SE |
| K831470 | PTH MRCEW · Traditional | 06/22/1983SE |
| K823016 | Candida Detection SystemLHK · Traditional | 12/28/1982SE |
| K812056 | Spectro FeiritinDBF · Traditional | 08/12/1981SE |
Questions and answers
When was Epo-Ria cleared by the FDA?
Epo-Ria (K910481) received a 510(k) decision of Substantially Equivalent on November 29, 1991, 296 days after the submission was received.
What is the product code of K910481?
The FDA product code is GGT – Assay, Erythropoietin, a Class II (moderate risk) device regulated under 21 CFR 864.7250.