ACTIVAT-PARTIAL THROMBO-PLASTIN
FDA 510(k) clearance K830320 · decided 1983-04-05
Clearance details
- K-number
- K830320
- Device name
- ACTIVAT-PARTIAL THROMBO-PLASTIN
- Applicant
- Helena Laboratories
- Decision
- Substantially Equivalent
- Date received
- 1983-01-31
- Decision date
- 1983-04-05
- Days to decision
- 64 days
- Clearance type
- Traditional
- Product code
- GGW
- Device class
- 2
- Regulation number
- 864.7925
- Medical specialty
- Hematology
- Advisory committee
- Hematology
- Location
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.