510(k) K862089
- Device
- V-MARC 88A COMPUTER
- Applicant
- V.MARC, A DIV. OF PICTORIAL, INC.
- 510(k) number
- K862089
- Product code
- KQH
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1986-07-10
- Date received
- 1986-06-02
- Regulation
- 864.5300
- Classification name
- Red-cell Indices
- Medical specialty
- Hematology
- Review panel
- Hematology
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- JAMES M CONNOLLY
- Address
- 8081 Zionsville Rd. Box 68886 Indianapolis IN US 46268 46268
Source Documents#
510(k) summary PDF not indicated by FDA
Legacy Summary#
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FDA Review#
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