510(k) K771777
- Device
- PONCEAU S CONCENTRATE
- Applicant
- SIGMA CHEMICAL CO.
- 510(k) number
- K771777
- Product code
- HZO
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1977-10-25
- Date received
- 1977-09-20
- Regulation
- 864.1850
- Classification name
- Stain, Ponceau
- Medical specialty
- Hematology
- Review panel
- Clinical Chemistry
- 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#
- 9610140
- 1618982
- 3003703247
Source Documents#
510(k) summary PDF not indicated by FDA
Legacy Summary#
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FDA Review#
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