Predicta Erythropoietin Kit (Modification)
FDA 510(k) K954898 · Genzyme Corp.
510(k) numberK954898
Submission
- Device name
- Predicta Erythropoietin Kit (Modification)
- Applicant
- Genzyme Corp.
Cambridge, MA, US - Received
- September 20, 1995
- Decision date
- February 5, 1996
- 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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Questions and answers
When was Predicta Erythropoietin Kit (Modification) cleared by the FDA?
Predicta Erythropoietin Kit (Modification) (K954898) received a 510(k) decision of Substantially Equivalent on February 5, 1996, 138 days after the submission was received.
What is the product code of K954898?
The FDA product code is GGT – Assay, Erythropoietin, a Class II (moderate risk) device regulated under 21 CFR 864.7250.