HDL CHOLESTEROL REAGENT
FDA 510(k) clearance K812574 · decided 1981-09-24
Clearance details
- K-number
- K812574
- Device name
- HDL CHOLESTEROL REAGENT
- Applicant
- Pointe Scientific, Inc.,
- Decision
- Substantially Equivalent
- Date received
- 1981-09-09
- Decision date
- 1981-09-24
- Days to decision
- 15 days
- Clearance type
- Traditional
- Product code
- LBR
- Device class
- 1
- Regulation number
- 862.1475
- 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 |
|---|---|---|
| Liquid HDL (PEG) Cholesterol Reagent Set. Pointe Scientific HDL Cholesterol Reagent Set, P recall (Z-0859-2010) | Pointe Scientific, Inc. | 2010-02-25 |
| Liquid HDL (PEG) Cholesterol Reagent, Pointe Scientific, Inc, Canton, MI; Catalog # 7-H751 recall (Z-0860-2010) | Pointe Scientific, Inc. | 2010-02-25 |