Erythropoietin Immunoassay Kit
FDA 510(k) K952559 · Nichols Institute
510(k) numberK952559
Submission
- Device name
- Erythropoietin Immunoassay Kit
- Applicant
- Nichols Institute
San Juan Capistrano, CA, US - Received
- June 2, 1995
- Decision date
- May 29, 1996
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- GGT – Assay, Erythropoietin
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 864.7250
- Specialty
- Hematology
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|---|---|---|---|
| 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 |
| 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 |
| K932650 | Erythropoietin Immunoassay KitGGT · Traditional | Nichols Institute | 03/11/1994SE |
More from Nichols Institute
| 510(k) | Device | Decision |
|---|---|---|
| K952505 | Insulin-Like Growth Factor I (Igf-I), Immunoradiometeric Assay (Irma)CFL · Traditional | 07/03/1995SE |
| K946247 | IGFBP-3; Insulin-Like Growth Factor Binding PROTEIN-3CFL · Traditional | 06/23/1995SE |
| K950524 | Nichols Institute Diagnostics Dhea-S Chemiluminescence ImmunoassayJKC · Traditional | 05/15/1995SE |
| K932650 | Erythropoietin Immunoassay KitGGT · Traditional | 03/11/1994SE |
| K931600 | Chemiluminescence Free T3 ImmunoassayCDP · Traditional | 09/08/1993SE |
| K931777 | Apo A-1 Chemiluminescence AssayMSJ · Traditional | 08/16/1993SE |
| K931601 | Chemiluminescence Dhea-S ImmunoassayJKC · Traditional | 07/27/1993SE |
| K926396 | Adrenocorticotropic/Acth Analysis ProductCKG · Traditional | 07/27/1993SE |
| K931311 | Thyroid Peroxidase Auto Antibodies(Tpo) Immun KitJZO · Traditional | 05/14/1993SE |
| K930777 | Thyroglobulin Autoantibody Immunoassay KitJNL · Traditional | 04/08/1993SE |
Questions and answers
When was Erythropoietin Immunoassay Kit cleared by the FDA?
Erythropoietin Immunoassay Kit (K952559) received a 510(k) decision of Substantially Equivalent on May 29, 1996, 362 days after the submission was received.
What is the product code of K952559?
The FDA product code is GGT – Assay, Erythropoietin, a Class II (moderate risk) device regulated under 21 CFR 864.7250.