510(k) K981338
- Device
- LD-1
- Applicant
- ABBOTT LABORATORIES
- 510(k) number
- K981338
- Product code
- JGF
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1998-05-18
- Date received
- 1998-04-13
- Regulation
- 862.1445
- Classification name
- Differential Rate Kinetic Method, Lactate Dehydrogenase Isoenzymes
- Medical specialty
- Clinical Chemistry
- Review panel
- Clinical Chemistry
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- MIKE LITTLEFIELD
- Address
- 1920 Hurd Dr. Irving TX US 75038 75038
FDA Registration Numbers#
- 3014325803
Source Documents#
Other 510(k) Records For Product Code JGF #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K925188 | ABBOTT QUICKSTART LD-1, MODIFICATION | Em Diagnostic Systems, Inc. | 1993-02-05 |
| K914261 | ABBOTT QUICKSTART LD-1,#5A30 | Em Diagnostic Systems, Inc. | 1991-10-21 |
| K890996 | LD1 ISOENZYME REAGENT KIT | Trace Scientific , Ltd. | 1989-05-05 |
| K871240 | ABBOTT A-GENT LD-1 ISOZYME REAGENT | Abbott Laboratories | 1987-05-13 |
| K860367 | MAGNESIUM (SUBSTRATE, ENZYME, REAGENT) | Alpkem Corp. | 1986-04-11 |
Legacy Summary#
summary
FDA Review#
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