LD-1
FDA 510(k) K981338 · Abbott Laboratories
510(k) numberK981338
Submission
- Device name
- LD-1
- Applicant
- Abbott Laboratories
Irving, TX, US - Received
- April 13, 1998
- Decision date
- May 18, 1998
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary 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 |
|---|---|---|---|
| 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 |
| K860367 | Magnesium (Substrate, Enzyme, Reagent)JGF · Traditional | Alpkem Corp. | 04/11/1986SE |
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Questions and answers
When was LD-1 cleared by the FDA?
LD-1 (K981338) received a 510(k) decision of Substantially Equivalent on May 18, 1998, 35 days after the submission was received.
What is the product code of K981338?
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.