510(k) K936016
- Device
- QUANTIKINE IVD ERYTHROPOIETIN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA)
- Applicant
- R & D SYSTEMS, INC.
- 510(k) number
- K936016
- Product code
- GGT
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1994-07-19
- Date received
- 1993-12-16
- Regulation
- 864.7250
- Classification name
- Assay, Erythropoietin
- Medical specialty
- Hematology
- Review panel
- Hematology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- JOHN G YAGER
- Address
- 614 Mckinley Pl. NE Minneapolis MN US 55413 55413
FDA Registration Numbers#
- 8032314
- 3002800697
- 1222302
- 2432235
- 2182501
- 2245285
- 2025099
- 3002806944
- 2122870
Source Documents#
Legacy Summary#
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FDA Review#
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