COXSACKIE A24 VIRUS MONOCLONAL ANTIBODY
FDA 510(k) clearance K936089 · decided 1995-09-08
Clearance details
- K-number
- K936089
- Device name
- COXSACKIE A24 VIRUS MONOCLONAL ANTIBODY
- Applicant
- Chemicon Intl., Inc.
- Decision
- Substantially Equivalent
- Date received
- 1993-12-21
- Decision date
- 1995-09-08
- Days to decision
- 626 days
- Clearance type
- Traditional
- Product code
- GNM
- Device class
- 1
- Regulation number
- 866.3145
- 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 |
|---|---|---|
| COCKSACKIEVIRUS B6 MONOCLONAL ANTIBODY (K936254) | Light Diagnostics | 1995-09-08 |
| COXSACKIEVIRUS B3 MONOCLONAL ANTIBODY (K936251) | Light Diagnostics | 1995-09-08 |
| ENTEROVIRUS MONOCL ANTIBODY DET OF COXSACKIE A9 VIRUS (K936073) | Chemicon Intl., Inc. | 1995-09-08 |
| COXSACKIEVIRUS B BLEND MONOCLONAL ANTIBODIES (K940471) | Chemicon Intl., Inc. | 1995-09-08 |
| COXSACKIEVIRUS B@ MONOCLONAL ANTIBODY (K936252) | Light Diagnostics | 1995-09-08 |
| COXSACKIEVIRUS B4 MONOCLONAL ANTIBODY (K936253) | Light Diagnostics | 1995-09-08 |
| COXSACKIEVIRUS B5 MONOCLONAL ANTIBODY (K940472) | Chemicon Intl., Inc. | 1995-09-08 |
| COXSACKIEVIRUS B1 MONOCLONAL ANTIBODY (K936145) | Chemicon Intl., Inc. | 1995-09-08 |
Recalls involving this device
No recalls on record reference this clearance.