Raichem(Tm) Magnesium Reagent, Enzymatic
FDA 510(k) K880880 · Reagents Applications, Inc.
510(k) numberK880880
Submission
- Device name
- Raichem(Tm) Magnesium Reagent, Enzymatic
- Applicant
- Reagents Applications, Inc.
San Diego, CA, US - Received
- March 2, 1988
- Decision date
- May 27, 1988
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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 |
|---|---|---|
| K982056 | Raichem CO2 ReagentKHS · Special | 06/24/1998SE |
| K972853 | Cholesterol Rapid Liquid ReagentCHH · Traditional | 09/24/1997SE |
| K922904 | Rai-Trol Fructosamine Serum Controls I and IIJJX · Traditional | 07/30/1992SE |
| K915191 | Rai-Trol Elevated Lipids ControlJJY · Traditional | 12/18/1991SE |
| K913398 | Raichem(Tm) Creatine Kinase-Mb ReagentCGS · Traditional | 09/25/1991SE |
| K911900 | Raichem Spia C3 ReagentCZW · Traditional | 05/09/1991SE |
| K911899 | Raichem Spia C4 ReagentDBI · Traditional | 05/09/1991SE |
| K911898 | Raichem(Tm) Spia(Tm) Haptoglobin ReagentDAD · Traditional | 05/08/1991SE |
| K905085 | Raichem GGT ReagentJQB · Traditional | 12/20/1990SE |
| K905084 | Raichem Creatine Kinase Reagent, Optimized UVCGS · Traditional | 12/20/1990SE |
Questions and answers
When was Raichem(Tm) Magnesium Reagent, Enzymatic cleared by the FDA?
Raichem(Tm) Magnesium Reagent, Enzymatic (K880880) received a 510(k) decision of Substantially Equivalent on May 27, 1988, 86 days after the submission was received.
What is the product code of K880880?
The FDA product code is JGJ – Photometric Method, Magnesium, a Class I (low risk) device regulated under 21 CFR 862.1495.