510(k) K842834
- Device
- HEP-2 CELLS
- Applicant
- BARTELS IMMUNODIAGNOSTIC SUPPLIES, INC.
- 510(k) number
- K842834
- Product code
- KJR
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1984-08-28
- Date received
- 1984-07-20
- Regulation
- 864.1850
- Classification name
- Erythrosin B
- Medical specialty
- Hematology
- Review panel
- Immunology
- 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#
- 1836161
- 1045125
- 9610140
- 8030607
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code KJR #
Legacy Summary#
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FDA Review#
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