510(k) K792552
- Device
- AMIDO BLACK 10B STAIN
- Applicant
- ELECTROPHORESIS CORP. OF AMERICA
- 510(k) number
- K792552
- Product code
- HZZ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1979-12-18
- Date received
- 1979-12-10
- Regulation
- 864.1850
- Classification name
- Sudan Black 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#
- 1000138378
- 3008776165
- 1937990
- 2013736
- 2250039
- 3008174888
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code HZZ #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K843684 | SIGMA SUDAN BLACK REAGENT 380-1 | Sigma Chemical Co. | 1984-10-31 |
Legacy Summary#
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FDA Review#
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