Magnesium Product No's, 112-01, 112-02
FDA 510(k) K991761 · A.P. Total Care, Inc.
510(k) numberK991761
Submission
- Device name
- Magnesium Product No's, 112-01, 112-02
- Applicant
- A.P. Total Care, Inc.
Bridgeport, CT, US - Received
- May 24, 1999
- Decision date
- September 2, 1999
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- JGJ – Photometric Method, Magnesium
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.1495
- Specialty
- Clinical Chemistry
Other 510(k)s with product code JGJ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K181748 | MagnesiumJGJ · Traditional | Abbott Laboratories | 09/12/2018SE |
| K173294 | MagnesiumJGJ · Traditional | Abbott Laboratories | 05/18/2018SE |
| K162200 | Randox RX Daytona Plus Magnesium (MG)JGJ · Traditional | Randox Laboratories, Ltd. | 04/28/2017SE |
| K162399 | Atellica CH Magnesium (Mg)JGJ · Traditional | Siemens Healthcare Diagnostics, Inc. | 01/19/2017SE |
| K122302 | Ace Magnesium RegentJGJ · Special | Alfa Wassermann Diagnostics Technologies, LLC | 08/27/2012SE |
| K111915 | Magnesium AssayJGJ · Traditional | Sekisui Diagnostics P.E.I., Inc. | 12/02/2011SE |
| K092737 | Easyra MG Reagent, Model 10220JGJ · Special | Medica Corp. | 11/17/2009SE |
| K091910 | Piccolo Magnesium Test SystemJGJ · Special | Abaxis, Inc. | 10/01/2009SE |
| K063208 | Magnesium Assay (XB), Models 125-12, 125-50 and 125-S7JGJ · Traditional | Diagnostic Chemicals , Ltd. | 01/19/2007SE |
| K040508 | Vitalab Magnesium ReagentJGJ · Traditional | Clinical Data, Inc. | 03/08/2004SE |
More from Clinical Data, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K991246 | Fructosamine, Model FR 106-01LCP · Traditional | 12/16/1999SE |
| K991762 | Alkaline Phophatase (Alp), Product No's 118-01, 118-02CJE · 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 |
| K991870 | Electrolytes (Na+, K+, Cl-), Product No's 114-01, 114-02, 114-03CGZ · Traditional | 07/30/1999SE |
| 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 Magnesium Product No's, 112-01, 112-02 cleared by the FDA?
Magnesium Product No's, 112-01, 112-02 (K991761) received a 510(k) decision of Substantially Equivalent on September 2, 1999, 101 days after the submission was received.
What is the product code of K991761?
The FDA product code is JGJ – Photometric Method, Magnesium, a Class I (low risk) device regulated under 21 CFR 862.1495.