PSI CALCIUM REAGENT
FDA 510(k) clearance K822469 · decided 1982-09-14
Clearance details
- K-number
- K822469
- Device name
- PSI CALCIUM REAGENT
- Applicant
- Pointe Scientific, Inc.,
- Decision
- Substantially Equivalent
- Date received
- 1982-08-17
- Decision date
- 1982-09-14
- Days to decision
- 28 days
- Clearance type
- Traditional
- Product code
- CIC
- Device class
- 2
- Regulation number
- 862.1145
- 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 |
|---|---|---|
| Calcium Reagent Set. Pointe Scientific Liquid Hitachi Calcium Reagent Set, Pointe Scientif recall (Z-1041-2010) | Pointe Scientific, Inc. | 2010-03-10 |
| Calcium (CPC) R1 Reagent Set. Pointe Scientific Liquid Calcium (CPC) R1 Reagent Set, Point recall (Z-1042-2010) | Pointe Scientific, Inc. | 2010-03-10 |
| Calcium (CPC) R2 Reagent Set. Pointe Scientific Liquid Calcium (CPC) R2 Reagent Set, Point recall (Z-1043-2010) | Pointe Scientific, Inc. | 2010-03-10 |