Epo-Trac(Tm) 125I Radioimmunoassay (Ria)
FDA 510(k) K902639 · Incstar Corp.
510(k) numberK902639
Submission
- Device name
- Epo-Trac(Tm) 125I Radioimmunoassay (Ria)
- Applicant
- Incstar Corp.
Stillwater, MN, US - Received
- June 14, 1990
- Decision date
- August 22, 1990
- 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
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|---|---|---|---|
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| 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 |
|---|---|---|
| K963289 | Incstar Toxoplasma Igm Capture Elisa AssayLGD · Traditional | 05/01/1997SE |
| K963297 | Incstar Toxoplasma Igg Fast Elisa Assay (CAT.#7560)LGD · Traditional | 12/16/1996SE |
| K963296 | Incstar Toxoplasma Igg Alisa Assay (CAT.#7565)LGD · Traditional | 12/16/1996SE |
| K960367 | Incstar Rubella Igg Elisa AssayLFX · Traditional | 10/24/1996SE |
| K960358 | Incstar Rubella Igg Fast Elisa AssayLFX · Traditional | 10/24/1996SE |
| K960434 | Incstar Cytomegalovirus Igm Capture Elisa Assay Model 8530LFZ · Traditional | 10/17/1996SE |
| K953567 | Incstar 25-HYDROXYVITMIN D 1251 RiaMRG · Traditional | 09/25/1996SE |
| K955363 | Incstar HSZ I/Ii Igg Elisa AssayIGC · Traditional | 07/24/1996SE |
| K955362 | Incstar HSV I/Ii Igg Fast Elisa AssayIGC · Traditional | 07/24/1996SE |
| K955361 | Incstar Cytomegalovirus Igg Elisa AssayLFZ · Traditional | 07/22/1996SE |
Questions and answers
When was Epo-Trac(Tm) 125I Radioimmunoassay (Ria) cleared by the FDA?
Epo-Trac(Tm) 125I Radioimmunoassay (Ria) (K902639) received a 510(k) decision of Substantially Equivalent on August 22, 1990, 69 days after the submission was received.
What is the product code of K902639?
The FDA product code is GGT – Assay, Erythropoietin, a Class II (moderate risk) device regulated under 21 CFR 864.7250.