Abbott Quickstart LD-1, Modification
FDA 510(k) K925188 · Em Diagnostic Systems, Inc.
510(k) numberK925188
Submission
- Device name
- Abbott Quickstart LD-1, Modification
- Applicant
- Em Diagnostic Systems, Inc.
Gibbstown, NJ, US - Received
- October 8, 1992
- Decision date
- February 5, 1993
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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 |
| 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 |
| K860367 | Magnesium (Substrate, Enzyme, Reagent)JGF · Traditional | Alpkem Corp. | 04/11/1986SE |
More from Alpkem Corp.
| 510(k) | Device | Decision |
|---|---|---|
| K935181 | Aspartate Aminotransferase (Ast) TestCIT · Traditional | 01/27/1994SE |
| K935180 | Alanine Aminotransferase (Alt) TestCKA · Traditional | 01/13/1994SE |
| K935179 | Emds Albumin (Alb) TestCIX · Traditional | 12/17/1993SE |
| K935178 | Emds Phosphorous (Phos) TestCEO · Traditional | 12/17/1993SE |
| K935177 | Gamma-Glutamyl Transferase (GGT) TestJQB · Traditional | 12/16/1993SE |
| K935176 | Iron TestJIY · Traditional | 12/16/1993SE |
| K935175 | Lactate Dehydrogenase (LD)CFJ · Traditional | 12/16/1993SE |
| K935174 | Total Protein Test (Tpro)CEK · Traditional | 12/16/1993SE |
| K935136 | Cholesterol (Chol) Test Item No. 65410CHH · Traditional | 12/16/1993SE |
| K935183 | Emds Magnesium (MG) TestJGJ · Traditional | 12/09/1993SE |
Questions and answers
When was Abbott Quickstart LD-1, Modification cleared by the FDA?
Abbott Quickstart LD-1, Modification (K925188) received a 510(k) decision of Substantially Equivalent on February 5, 1993, 120 days after the submission was received.
What is the product code of K925188?
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.