V-MARC 88A COMPUTER
FDA 510(k) clearance K862089 · decided 1986-07-10
Clearance details
- K-number
- K862089
- Device name
- V-MARC 88A COMPUTER
- Applicant
- V.Marc, A Div. of Pictorial, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1986-06-02
- Decision date
- 1986-07-10
- Days to decision
- 38 days
- Clearance type
- Traditional
- Product code
- KQH
- Device class
- 2
- Regulation number
- 864.5300
- Medical specialty
- Hematology
- Advisory committee
- Hematology
- Location
- Indianapolis, IN, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.