510(k) K792549
- Device
- FAT RED 7B STAIN SET
- Applicant
- ELECTROPHORESIS CORP. OF AMERICA
- 510(k) number
- K792549
- Product code
- HYD
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1979-12-18
- Date received
- 1979-12-10
- Regulation
- 864.1850
- Classification name
- Fast Red Salt B
- Medical specialty
- Hematology
- 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#
- 3008174888
Source Documents#
510(k) summary PDF not indicated by FDA
Legacy Summary#
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FDA Review#
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