SDI PREPAX COUNTAPETTE KIT
FDA 510(k) clearance K892658 · decided 1989-05-24
Clearance details
- K-number
- K892658
- Device name
- SDI PREPAX COUNTAPETTE KIT
- Applicant
- Scientific Distributors, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1989-04-13
- Decision date
- 1989-05-24
- Days to decision
- 41 days
- Clearance type
- Traditional
- Product code
- JCG
- Device class
- 1
- Regulation number
- 864.8200
- Medical specialty
- Hematology
- Advisory committee
- Hematology
- Location
- Norwood, MA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.