510(k) K823329
- Device
- PAPINCOLABU STAIN EA-36/50/65 & OG-6
- Applicant
- ACCRA LABORATORIES, INC.
- 510(k) number
- K823329
- Product code
- HZL
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1982-12-28
- Date received
- 1982-11-08
- Regulation
- 864.1850
- Classification name
- Phloxine 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#
- 3017970519
- 2250039
- 3008174888
- 1045125
Source Documents#
510(k) summary PDF not indicated by FDA
Legacy Summary#
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FDA Review#
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