510(k) K955363
- Device
- INCSTAR HSZ I/II IGG ELISA ASSAY
- Applicant
- INCSTAR CORP.
- 510(k) number
- K955363
- Product code
- IGC
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1996-07-24
- Date received
- 1995-11-22
- Regulation
- 864.4010
- Classification name
- Formalin-saline
- Medical specialty
- Pathology
- Review panel
- Microbiology
- Device class
- 1
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- MARY FRICK
- Address
- 1990 Industrial Blvd. P.O. Box 285 Stillwater MN US 55082 55082
FDA Registration Numbers#
- 3008485841
- 3010939897
- 1000191380
- 3013301147
- 1123010
- 3002805583
Source Documents#
Other 510(k) Records For Product Code IGC #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K955362 | INCSTAR HSV I/II IGG FAST ELISA ASSAY | Incstar Corp. | 1996-07-24 |
Legacy Summary#
summary
FDA Review#
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