510(k) K880549
- Device
- DIACYTE FIXATIVE SOLUTION
- Applicant
- CYTOCORP, INC.
- 510(k) number
- K880549
- Product code
- LDY
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1988-04-01
- Date received
- 1988-02-09
- Regulation
- 864.4010
- Classification name
- Fixative, Formalin-containing
- Medical specialty
- Pathology
- Review panel
- Pathology
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- KAY MAKSEM
- Address
- 601 Rockwell Ave. Suite 314 Cleveland OH US 44114 44114
FDA Registration Numbers#
- 1640981
- 2244900
- 1831638
- 3015505238
- 1930126
- 1419341
- 3003335080
- 3003703247
- 3004074729
- 3002805583
- 1063851
- 3008174888
- 3007496191
- 3009963993
- 3010194621
- 2247035
- 3010692993
- 3010420046
- 2013736
- 1831312
Source Documents#
510(k) summary PDF not indicated by FDA
Legacy Summary#
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FDA Review#
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