MAGNESIUM (SUBSTRATE, ENZYME, REAGENT)
FDA 510(k) clearance K860367 · decided 1986-04-11
Clearance details
- K-number
- K860367
- Device name
- MAGNESIUM (SUBSTRATE, ENZYME, REAGENT)
- Applicant
- Alpkem Corp.
- Decision
- Substantially Equivalent
- Date received
- 1986-02-03
- Decision date
- 1986-04-11
- Days to decision
- 67 days
- Clearance type
- Traditional
- Product code
- JGF
- Device class
- 2
- Regulation number
- 862.1445
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Clackamas, OR, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| LD-1 (K981338) | Abbott Laboratories | 1998-05-18 |
| ABBOTT QUICKSTART LD-1, MODIFICATION (K925188) | Em Diagnostic Systems, Inc. | 1993-02-05 |
| ABBOTT QUICKSTART LD-1,#5A30 (K914261) | Em Diagnostic Systems, Inc. | 1991-10-21 |
| LD1 ISOENZYME REAGENT KIT (K890996) | Trace Scientific , Ltd. | 1989-05-05 |
| ABBOTT A-GENT LD-1 ISOZYME REAGENT (K871240) | Abbott Laboratories | 1987-05-13 |
Recalls involving this device
No recalls on record reference this clearance.