510(k) K843684
- Device
- SIGMA SUDAN BLACK REAGENT 380-1
- Applicant
- SIGMA CHEMICAL CO.
- 510(k) number
- K843684
- Product code
- HZZ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1984-10-31
- Date received
- 1984-09-18
- Regulation
- 864.1850
- Classification name
- Sudan Black B
- Medical specialty
- Hematology
- Review panel
- Hematology
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- LEO BRESSLER
- Address
- P.O. Box 14508 St. Louis MO US 63178 63178
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 |
|---|---|---|---|
| K792552 | AMIDO BLACK 10B STAIN | Electrophoresis Corp. of America | 1979-12-18 |
Legacy Summary#
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FDA Review#
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