ELECTROLYTES (NA+, K+, CL-), PRODUCT NO'S 114-01, 114-02, 114-03
FDA 510(k) clearance K991870 · decided 1999-07-30
Clearance details
- K-number
- K991870
- Device name
- ELECTROLYTES (NA+, K+, CL-), PRODUCT NO'S 114-01, 114-02, 114-03
- Applicant
- A.P. Total Care, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1999-06-01
- Decision date
- 1999-07-30
- Days to decision
- 59 days
- Clearance type
- Traditional
- Product code
- CGZ
- Device class
- 2
- Regulation number
- 862.1170
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Bridgeport, CT, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.