510(k) K915838
- Device
- OPUS FERRITIN TEST SYSTEM
- Applicant
- PB DIAGNOSTIC SYSTEMS, INC.
- 510(k) number
- K915838
- Product code
- DGE
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1992-03-18
- Date received
- 1991-12-24
- Regulation
- 866.5510
- Classification name
- Igd, Rhodamine, Antigen, Antiserum, Control
- Medical specialty
- Immunology
- Review panel
- Immunology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- LORI BARANAUSKAS
- Address
- 151 University Ave. Westwood MA US 02090 02090
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 |
|---|---|---|---|
| K871972 | STRATUS IGE FLUOROMETRIC ENZYME IMMUNOASSAY | American Dade | 1987-07-21 |
Legacy Summary#
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FDA Review#
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