TOTAL BILIRUBIN REAGENT SET
FDA 510(k) clearance K040391 · decided 2004-06-02
Clearance details
- K-number
- K040391
- Device name
- TOTAL BILIRUBIN REAGENT SET
- Applicant
- Pointe Scientific, Inc.,
- Decision
- Substantially Equivalent
- Date received
- 2004-02-17
- Decision date
- 2004-06-02
- Days to decision
- 106 days
- Clearance type
- Traditional
- Product code
- CIG
- Device class
- 2
- Regulation number
- 862.1110
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Lincoln Park, MI, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Pointe Scientific Hitachi Total Bilirubin Rl Reagent Product Usage: Two part Chemistry Rea recall (Z-2586-2017) | Medtest Holdings, Inc. | 2017-06-14 |
| Pointe Scientific Direct Bilirubin Reagent Set, Pointe Scientific Inc., Canton, MI., Catal recall (Z-1014-2010) | Pointe Scientific, Inc. | 2010-03-05 |
| Pointe Scientific Direct Bilirubin Reagent Set, Pointe Scientific Inc., Canton, MI. The de recall (Z-1202-2009) | Pointe Scientific, Inc. | 2009-04-17 |