510(k) K855034
- Device
- AMERICAN HISTO-ID SYS PRIMARY KIT PSA PROSTATE ANT
- Applicant
- BARTELS IMMUNODIAGNOSTIC SUPPLIES, INC.
- 510(k) number
- K855034
- Product code
- LIJ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1986-03-11
- Date received
- 1985-12-17
- Regulation
- 864.4400
- Classification name
- Peroxidase Anti-peroxidase Immunohistochemical Stain
- Medical specialty
- Pathology
- Review panel
- Pathology
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- BARTELS
- Address
- P.O. Box 3093 Bellevue WA US 98009 98009
FDA Registration Numbers#
- 2022180
- 2916205
- 3009189893
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code LIJ #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K820336 | DAKO PAP KIT K509 | Dako Corp. | 1982-07-13 |
Legacy Summary#
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FDA Review#
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