Immulite Epo, Model #'S Lkepz & LKEP1
FDA 510(k) K983203 · Diagnostic Products Corp.
510(k) numberK983203
Submission
- Device name
- Immulite Epo, Model #'S Lkepz & LKEP1
- Applicant
- Diagnostic Products Corp.
Los Angeles, CA, US - Received
- September 14, 1998
- Decision date
- July 12, 1999
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary 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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|---|---|---|---|
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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 |
| 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 |
| K932650 | Erythropoietin Immunoassay KitGGT · Traditional | Nichols Institute | 03/11/1994SE |
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| K023304 | Immulite/Immulite 1000 Calcitonin, Model LKCL and Immulite 2000 Calcitonin, Model L2KCLJKR · Traditional | 12/09/2002SE |
| K022603 | Immulite 1000 Automated Immunoassay AnalyzerCEW · Special | 08/21/2002SE |
Questions and answers
When was Immulite Epo, Model #'S Lkepz & LKEP1 cleared by the FDA?
Immulite Epo, Model #'S Lkepz & LKEP1 (K983203) received a 510(k) decision of Substantially Equivalent on July 12, 1999, 301 days after the submission was received.
What is the product code of K983203?
The FDA product code is GGT – Assay, Erythropoietin, a Class II (moderate risk) device regulated under 21 CFR 864.7250.