510(k) K902639
- Device
- EPO-TRAC(TM) 125I RADIOIMMUNOASSAY (RIA)
- Applicant
- INCSTAR CORP.
- 510(k) number
- K902639
- Product code
- GGT
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1990-08-22
- Date received
- 1990-06-14
- Regulation
- 864.7250
- Classification name
- Assay, Erythropoietin
- Medical specialty
- Hematology
- Review panel
- Hematology
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- DAVID H SHORT
- Address
- 1990 Insustrial Blvd. P.O. Box 285 Stillwater MN US 55082 55082
FDA Registration Numbers#
- 8032314
- 3002800697
- 1222302
- 2432235
- 2182501
- 2245285
- 2025099
- 3002806944
- 2122870
Source Documents#
510(k) summary PDF not indicated by FDA
Legacy Summary#
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FDA Review#
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