LIQUID LDH-L REAGENT SET
FDA 510(k) clearance K973589 · decided 1997-10-08
Clearance details
- K-number
- K973589
- Device name
- LIQUID LDH-L REAGENT SET
- Applicant
- Pointe Scientific, Inc.,
- Decision
- Substantially Equivalent
- Date received
- 1997-09-22
- Decision date
- 1997-10-08
- Days to decision
- 16 days
- Clearance type
- Traditional
- Product code
- CFJ
- Device class
- 2
- Regulation number
- 862.1440
- 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 Lactate Dehydrogenase (Liquid) Reagent Set Model Number(s): L7572. For t recall (Z-2165-2017) | Medtest Holdings, Inc. | 2017-05-26 |