QUAN-8 MULT-COMP FACTOR VIII ASSAY KIT
FDA 510(k) clearance K761058 · decided 1977-02-07
Clearance details
- K-number
- K761058
- Device name
- QUAN-8 MULT-COMP FACTOR VIII ASSAY KIT
- Applicant
- Bio/Data Corp.
- Decision
- Substantially Equivalent
- Date received
- 1976-11-18
- Decision date
- 1977-02-07
- Days to decision
- 81 days
- Clearance type
- Traditional
- Product code
- GGP
- Device class
- 2
- Regulation number
- 864.7290
- 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.