510(k) K892658
- Device
- SDI PREPAX COUNTAPETTE KIT
- Applicant
- SCIENTIFIC DISTRIBUTORS, INC.
- 510(k) number
- K892658
- Product code
- JCG
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1989-05-24
- Date received
- 1989-04-13
- Regulation
- 864.8200
- Classification name
- Fluid, Diluting, Manual Cell
- Medical specialty
- Hematology
- Review panel
- Hematology
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- MICHAEL J BOYLE
- Address
- Bldg. 24 Endicott St. Norwood MA US 02062 02062
FDA Registration Numbers#
- 3003393069
Source Documents#
510(k) summary PDF not indicated by FDA
Legacy Summary#
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FDA Review#
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