Predicta Erythropoietin Kit (Modification)
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K954898 FDA 510(k)
- FDA Product Code
- GGT FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 864.7250 FDA 510(k)
- Regulation Number
- 864.7250 FDA 510(k)
- Advisory Committee
- Hematology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Predicta Erythropoietin Kit (Modification) is an in‑vitro assay device classified as an erythropoietin assay. It is designed to measure erythropoietin levels in clinical specimens, supporting hematology testing and related laboratory analyses.
The kit was cleared by the U.S. Food and Drug Administration through a traditional 510(k) submission (K954898) and is classified as a Class II device with product code GGT. It is listed under registration number 8032314 and is intended for single‑use in laboratory settings; no specific sterility or MRI safety information is provided.
Frequently asked questions
What is the Predicta Erythropoietin Kit used for?
The Predicta Erythropoietin Kit is an in-vitro assay device designed to measure erythropoietin levels in clinical specimens, supporting hematology testing and related laboratory analyses.
How is the Predicta Erythropoietin Kit supplied?
The kit is supplied as a complete in-vitro assay device for laboratory use. It is intended for single-use only and does not come with specific sterility or MRI safety information.
What is the regulatory status of the Predicta Erythropoietin Kit?
The kit was cleared by the U.S. Food and Drug Administration through a traditional 510(k) submission (K954898) and is classified as a Class II device with product code GGT. It is listed under registration number 8032314.
What sizes or models of the Predicta Erythropoietin Kit are available?
The device information does not specify multiple sizes or models. The available data refers only to the Predicta Erythropoietin Kit (Modification) as a single product configuration.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: PREDICTA ERYTHROPOIETIN KIT (MODIFICATION) (K954898) — FDA 510 (k ..., PDF K954898 - Predicta Erythropoietin Kit (Modification), PREDICTA ERYTHROPOIETIN KIT (K926390) — FDA 510(k) | Innolitics, Genzyme Predicta Erythropoietin Kit (5576) - Erythropoietin
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K954898 | Class II | Active |
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Manufacturer
- Manufacturer
- Genzyme Corp.
Sources (1)
- FDA 510(k) K954898 24 fields · synced Sep 25, 2026