Electrolytes (Na+, K+, Cl-), Product No's 114-01, 114-02, 114-03
FDA 510(k) K991870 · A.P. Total Care, Inc.
510(k) numberK991870
Submission
- Device name
- Electrolytes (Na+, K+, Cl-), Product No's 114-01, 114-02, 114-03
- Applicant
- A.P. Total Care, Inc.
Bridgeport, CT, US - Received
- June 1, 1999
- Decision date
- July 30, 1999
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- CGZ – Electrode, Ion-Specific, Chloride
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1170
- Specialty
- Clinical Chemistry
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More from Phoenix Diagnostics, Inc.
| 510(k) | Device | Decision |
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| K991246 | Fructosamine, Model FR 106-01LCP · Traditional | 12/16/1999SE |
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| K991761 | Magnesium Product No's, 112-01, 112-02JGJ · Traditional | 09/02/1999SE |
| K991664 | LDL Cholesterol, Product No's, 124-01, CH102-01LBS · Traditional | 08/19/1999SE |
| K991665 | HDL Cholesterol, Product No's 124-01, CH102-01LBS · Traditional | 08/10/1999SE |
| K991867 | Inorganic Phosphorus (Ip), Product No's, 112-01, 112-02CEO · Traditional | 08/02/1999SE |
| K991866 | Bilirubin, Total and Direct, Product No, 122-01, 122-02, 122-03, 122-04CIG · Traditional | 08/02/1999SE |
| K991666 | Tibc, Product No's 123-0, 123-02, FE109-01, FE109-02JMO · Traditional | 06/30/1999SE |
| K991663 | Ast/SgotCIT · Traditional | 06/30/1999SE |
| K991247 | Uric Acid, Model UA112-01KNK · Traditional | 05/25/1999SE |
Questions and answers
When was Electrolytes (Na+, K+, Cl-), Product No's 114-01, 114-02, 114-03 cleared by the FDA?
Electrolytes (Na+, K+, Cl-), Product No's 114-01, 114-02, 114-03 (K991870) received a 510(k) decision of Substantially Equivalent on July 30, 1999, 59 days after the submission was received.
What is the product code of K991870?
The FDA product code is CGZ – Electrode, Ion-Specific, Chloride, a Class II (moderate risk) device regulated under 21 CFR 862.1170.