Magnesium (Substrate, Enzyme, Reagent)
FDA 510(k) K860367 · Alpkem Corp.
510(k) numberK860367
Submission
- Device name
- Magnesium (Substrate, Enzyme, Reagent)
- Applicant
- Alpkem Corp.
Clackamas, OR, US - Received
- February 3, 1986
- Decision date
- April 11, 1986
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- JGF – Differential Rate Kinetic Method, Lactate Dehydrogenase Isoenzymes
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1445
- Specialty
- Clinical Chemistry
Other 510(k)s with product code JGF
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K981338 | LD-1JGF · Traditional | Abbott Laboratories | 05/18/1998SE |
| K925188 | Abbott Quickstart LD-1, ModificationJGF · Traditional | Em Diagnostic Systems, Inc. | 02/05/1993SE |
| K914261 | Abbott Quickstart LD-1,#5A30JGF · Traditional | Em Diagnostic Systems, Inc. | 10/21/1991SE |
| K890996 | LD1 Isoenzyme Reagent KitJGF · Traditional | Trace Scientific , Ltd. | 05/05/1989SE |
| K871240 | Abbott A-Gent LD-1 Isozyme ReagentJGF · Traditional | Abbott Laboratories | 05/13/1987SE |
More from Abbott Laboratories
| 510(k) | Device | Decision |
|---|---|---|
| K894011 | Total GalactoseKQP · Traditional | 01/11/1990SE |
| K891070 | Phenylalanine (Ninhydrin Reaction)JNB · Traditional | 10/27/1989SE |
| K890334 | Total Cholesterol ReagentCHH · Traditional | 05/03/1989SE |
| K890337 | Triglycerides - Gpo ReagentCDT · Traditional | 03/09/1989SE |
| K890336 | Glucose (God) ReagentCGA · Traditional | 02/27/1989SE |
| K890335 | Sodium Hydroxide Solution, Creatinine Reag./Dilu.CGE · Traditional | 02/17/1989SE |
| K890333 | Albumin ReagentEIX · Traditional | 02/17/1989SE |
| K890332 | RFA/2 Rapid Flow Analyzer W/ComputerJJC · Traditional | 02/17/1989SE |
| K883020 | RFA-300 Rapid Flow Analyzer W/ComputerJJF · Traditional | 09/02/1988SE |
| K852005 | MG ReagentJGJ · Traditional | 06/25/1985SE |
Questions and answers
When was Magnesium (Substrate, Enzyme, Reagent) cleared by the FDA?
Magnesium (Substrate, Enzyme, Reagent) (K860367) received a 510(k) decision of Substantially Equivalent on April 11, 1986, 67 days after the submission was received.
What is the product code of K860367?
The FDA product code is JGF – Differential Rate Kinetic Method, Lactate Dehydrogenase Isoenzymes, a Class II (moderate risk) device regulated under 21 CFR 862.1445.