510(k) K940363
- Device
- ENTEROVIRUS 70 MONCLONAL ANTIBODY
- Applicant
- LIGHT DIAGNOSTICS
- 510(k) number
- K940363
- Product code
- GOE
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1995-09-08
- Date received
- 1994-01-26
- Regulation
- 866.3405
- Classification name
- Antisera, Fluorescent, Poliovirus 1-3
- Medical specialty
- Microbiology
- Review panel
- Microbiology
- Device class
- 1
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- RICHARD P TRIGLIA
- Address
- 28835 Single Oak Dr. Temecula CA US 92590 92590
FDA Registration Numbers#
- 3003750284
- 1528450
Source Documents#
Other 510(k) Records For Product Code GOE #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K940017 | POLIOVIRUS 3 MONOCLONAL ANTIBODY | Light Diagnostics | 1995-09-12 |
| K940026 | POLIOVIRUS BLEND MONOCLONAL ANTIBODIES | Light Diagnostics | 1995-09-12 |
| K940027 | ENTEROVIRUS BLEND MONOCLONAL ANTIBODIES | Chemicon Intl., Inc. | 1995-09-12 |
| K940034 | POLIOVIRUS 2 MONOCLONAL ANTIBODY | Light Diagnostics | 1995-09-12 |
| K940473 | ENTEROVIRUS 71 MONOCLONAL ANTIBODY | Chemicon Intl., Inc. | 1995-09-12 |
| K940018 | POLIOVIRUS 1 MONOCLONAL ANTIBODY | Light Diagnostics | 1995-09-08 |
Legacy Summary#
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FDA Review#
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