CREATININE
FDA 510(k) clearance K830556 · decided 1983-03-24
Clearance details
- K-number
- K830556
- Device name
- CREATININE
- Applicant
- Pointe Scientific, Inc.,
- Decision
- Substantially Equivalent
- Date received
- 1983-02-23
- Decision date
- 1983-03-24
- Days to decision
- 29 days
- Clearance type
- Traditional
- Product code
- CGX
- Device class
- 2
- Regulation number
- 862.1225
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Pointe Scientific Creatinine Reagent Catalog number C7539-150 in vitro diagnostic C7539-15 recall (Z-2773-2015) | Pointe Scientific, Inc. | 2015-09-16 |
| Pointe Scientific Creatinine Reagent Set, Pointe Scientific, Inc., Canton, MI; Catalog # C recall (Z-1035-2010) | Pointe Scientific, Inc. | 2010-03-09 |
| Pointe Scientific Creatinine Reagent R2, Pointe Scientific, Inc., Canton, MI; Catalog 3-C7 recall (Z-1036-2010) | Pointe Scientific, Inc. | 2010-03-09 |