510(k) K820336
- Device
- DAKO PAP KIT K509
- Applicant
- DAKO CORP.
- 510(k) number
- K820336
- Product code
- LIJ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1982-07-13
- Date received
- 1982-02-08
- 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#
- Address
- 803 N. Front St. Suite 3 Mchenry IL US 60050 60050
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 |
|---|---|---|---|
| K855034 | AMERICAN HISTO-ID SYS PRIMARY KIT PSA PROSTATE ANT | Bartels Immunodiagnostic Supplies, Inc. | 1986-03-11 |
Legacy Summary#
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FDA Review#
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