510(k) K954515
- Device
- ENZYME LINKED IMMUNOABSORBENT ASSAY, RUBELLA
- Applicant
- PYRAMID BIOLOGICAL CORP.
- 510(k) number
- K954515
- Product code
- GOM
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1995-12-20
- Date received
- 1995-09-28
- Regulation
- 866.3510
- Classification name
- Antisera, Cf, Rubella
- Medical specialty
- Microbiology
- Review panel
- Microbiology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- JEANETTE PORRETTA
- Address
- 6454 Van Nuys Blvd., Suite 111 Van Nuys CA US 91401 91401
FDA Registration Numbers#
- 2032682
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code GOM #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K953826 | ENZYME LINKED UMMINOABSORBENT ASSAY, RUBELLA | Pyramid Biological Corp. | 1995-12-14 |
Legacy Summary#
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FDA Review#
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