NOVA II SODIUM/POTASSIUM/LITHIUM ANALYZER
FDA 510(k) clearance K863438 · decided 1986-09-29
Clearance details
- K-number
- K863438
- Device name
- NOVA II SODIUM/POTASSIUM/LITHIUM ANALYZER
- Applicant
- Nova Biomedical Corp.
- Decision
- Substantially Equivalent
- Date received
- 1986-09-05
- Decision date
- 1986-09-29
- Days to decision
- 24 days
- Clearance type
- Traditional
- Product code
- JJP
- Device class
- 1
- Regulation number
- 862.2050
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Walham, MA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| CENTRIPREP 100 (K900280) | Amicon, Inc. | 1990-02-16 |
| URINE DILUENT-FOR USE WITH ION SELECTIVE ELECTRODE (K860143) | Reagent Laboratory, Inc. | 1986-02-10 |
Recalls involving this device
No recalls on record reference this clearance.