Abbott A-Gent LD-1 Isozyme Reagent
FDA 510(k) K871240 · Abbott Laboratories
510(k) numberK871240
Submission
- Device name
- Abbott A-Gent LD-1 Isozyme Reagent
- Applicant
- Abbott Laboratories
Abbott Park, IL, US - Received
- March 27, 1987
- Decision date
- May 13, 1987
- 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 |
| K860367 | Magnesium (Substrate, Enzyme, Reagent)JGF · Traditional | Alpkem Corp. | 04/11/1986SE |
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Questions and answers
When was Abbott A-Gent LD-1 Isozyme Reagent cleared by the FDA?
Abbott A-Gent LD-1 Isozyme Reagent (K871240) received a 510(k) decision of Substantially Equivalent on May 13, 1987, 47 days after the submission was received.
What is the product code of K871240?
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.