INCSTAR EPSTEIN-BARR NUCLEAR ANTIGEN (EBNA_ IGG ELISA KIT
FDA 510(k) clearance K946158 · decided 1995-06-09
Clearance details
- K-number
- K946158
- Device name
- INCSTAR EPSTEIN-BARR NUCLEAR ANTIGEN (EBNA_ IGG ELISA KIT
- Applicant
- Incstar Corp.
- Decision
- Substantially Equivalent
- Date received
- 1994-12-08
- Decision date
- 1995-06-09
- Days to decision
- 183 days
- Clearance type
- Traditional
- Product code
- LLM
- Device class
- 1
- Regulation number
- 866.3235
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Stillwater, MN, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| DiaSorin ETI-EBNA-G kits, Catalog No. P001607A. In vitro diagnostic. For the qualitative a recall (Z-0755-2007) | Diasorin Inc. | 2007-04-24 |
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| CLINICAL ASSAYS (TM) GAMMADAB(R) [ 125 I ] (P790032/S003) | Incstar Corp. | 1993-07-23 |
| CLINICAL ASSAYS (TM) GAMMADAB(R) [ 125 I ] (P790032/S002) | Incstar Corp. | 1991-03-28 |
| GAMMA DAB (125I) AFP RIA KIT (P790032/S001) | Incstar Corp. | 1986-08-22 |
| GAMMA DAB (125I) AFP RIA KIT (P790032) | Incstar Corp. | 1986-04-30 |