ENTEROVIRUS BLEND MONOCLONAL ANTIBODIES
FDA 510(k) clearance K940027 · decided 1995-09-12
Clearance details
- K-number
- K940027
- Device name
- ENTEROVIRUS BLEND MONOCLONAL ANTIBODIES
- Applicant
- Chemicon Intl., Inc.
- Decision
- Substantially Equivalent
- Date received
- 1994-01-03
- Decision date
- 1995-09-12
- Days to decision
- 617 days
- Clearance type
- Traditional
- Product code
- GOE
- Device class
- 1
- Regulation number
- 866.3405
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Temecula, CA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| POLIOVIRUS BLEND MONOCLONAL ANTIBODIES (K940026) | Light Diagnostics | 1995-09-12 |
| ENTEROVIRUS 71 MONOCLONAL ANTIBODY (K940473) | Chemicon Intl., Inc. | 1995-09-12 |
| POLIOVIRUS 2 MONOCLONAL ANTIBODY (K940034) | Light Diagnostics | 1995-09-12 |
| POLIOVIRUS 3 MONOCLONAL ANTIBODY (K940017) | Light Diagnostics | 1995-09-12 |
| POLIOVIRUS 1 MONOCLONAL ANTIBODY (K940018) | Light Diagnostics | 1995-09-08 |
| ENTEROVIRUS 70 MONCLONAL ANTIBODY (K940363) | Light Diagnostics | 1995-09-08 |
Recalls involving this device
No recalls on record reference this clearance.