REAGENT, PARTIAL THROMBOPLASTIN
FDA 510(k) clearance K760499 · decided 1976-10-29
Clearance details
- K-number
- K760499
- Device name
- REAGENT, PARTIAL THROMBOPLASTIN
- Applicant
- Hyland Therapeutic Div., Travenol Laboratories
- Decision
- Substantially Equivalent
- Date received
- 1976-08-23
- Decision date
- 1976-10-29
- Days to decision
- 67 days
- Clearance type
- Traditional
- Advisory committee
- Unknown
- 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.