QUICKSTART UREA NITROGEN
FDA 510(k) clearance K914903 · decided 1991-12-31
Clearance details
- K-number
- K914903
- Device name
- QUICKSTART UREA NITROGEN
- Applicant
- Em Diagnostic Systems, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1991-11-01
- Decision date
- 1991-12-31
- Days to decision
- 60 days
- Clearance type
- Traditional
- Product code
- CDN
- Device class
- 2
- Regulation number
- 862.1770
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Gibbstown, NJ, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.