510(k) K871972
- Device
- STRATUS IGE FLUOROMETRIC ENZYME IMMUNOASSAY
- Applicant
- AMERICAN DADE
- 510(k) number
- K871972
- Product code
- DGE
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1987-07-21
- Date received
- 1987-05-21
- Regulation
- 866.5510
- Classification name
- Igd, Rhodamine, Antigen, Antiserum, Control
- Medical specialty
- Immunology
- Review panel
- Immunology
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- KAREN H DARCY
- Address
- P.O. Box 25101 Santa Ana CA US 92799 92799
FDA Registration Numbers#
- 3019906
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code DGE #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K915838 | OPUS FERRITIN TEST SYSTEM | Pb Diagnostic Systems, Inc. | 1992-03-18 |
Legacy Summary#
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FDA Review#
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