PROTEIN-BOUND GLUCOSE ASSAYN KIT
FDA 510(k) clearance K930823 · decided 1993-08-19
Clearance details
- K-number
- K930823
- Device name
- PROTEIN-BOUND GLUCOSE ASSAYN KIT
- Applicant
- Diagnostic Specialties
- Decision
- Substantially Equivalent
- Date received
- 1993-02-17
- Decision date
- 1993-08-19
- Days to decision
- 183 days
- Clearance type
- Traditional
- Product code
- LCP
- Device class
- 2
- Regulation number
- 864.7470
- Medical specialty
- Hematology
- Advisory committee
- Hematology
- Location
- Metuchen, NJ, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.