WIENER LAB. CALIBRATOR A PLUS, MODEL 2X3 ML CAT. NR. 1918006
FDA 510(k) clearance K024305 · decided 2003-03-18
Clearance details
- K-number
- K024305
- Device name
- WIENER LAB. CALIBRATOR A PLUS, MODEL 2X3 ML CAT. NR. 1918006
- Applicant
- Wiener Laboratories Saic
- Decision
- Substantially Equivalent
- Date received
- 2002-12-24
- Decision date
- 2003-03-18
- Days to decision
- 84 days
- Clearance type
- Traditional
- Product code
- JIX
- Device class
- 2
- Regulation number
- 862.1150
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Rosario, Santa Fe, AR
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.