COAGULATION CONTROL PLASMA (NORMAL & ABNORMAL)
FDA 510(k) clearance K884854 · decided 1989-01-30
Clearance details
- K-number
- K884854
- Device name
- COAGULATION CONTROL PLASMA (NORMAL & ABNORMAL)
- Applicant
- Precision Biologicals, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1988-11-18
- Decision date
- 1989-01-30
- Days to decision
- 73 days
- Clearance type
- Traditional
- Product code
- GGN
- Device class
- 2
- Regulation number
- 864.5425
- Medical specialty
- Hematology
- Advisory committee
- Hematology
- Location
- Dartmouth, CA
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.