SIGMA DIAGNOSTICS SIGMA-CAL, MODEL S2936
FDA 510(k) clearance K010652 · decided 2001-03-30
Clearance details
- K-number
- K010652
- Device name
- SIGMA DIAGNOSTICS SIGMA-CAL, MODEL S2936
- Applicant
- Sigma Diagnostics, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2001-03-05
- Decision date
- 2001-03-30
- Days to decision
- 25 days
- Clearance type
- Traditional
- Product code
- JIX
- Device class
- 2
- Regulation number
- 862.1150
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- St. Louis, MO, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.