INCSTAR HSZ I/II IGG ELISA ASSAY
FDA 510(k) clearance K955363 · decided 1996-07-24
Clearance details
- K-number
- K955363
- Device name
- INCSTAR HSZ I/II IGG ELISA ASSAY
- Applicant
- Incstar Corp.
- Decision
- Substantially Equivalent
- Date received
- 1995-11-22
- Decision date
- 1996-07-24
- Days to decision
- 245 days
- Clearance type
- Traditional
- Product code
- IGC
- Device class
- 1
- Regulation number
- 864.4010
- Medical specialty
- Pathology
- Advisory committee
- Pathology
- Location
- Stillwater, MN, 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 |
|---|---|---|
| INCSTAR HSV I/II IGG FAST ELISA ASSAY (K955362) | Incstar Corp. | 1996-07-24 |
Recalls involving this device
No recalls on record reference this clearance.
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 |