MAGNESIUM PROCEDURE
FDA 510(k) clearance K863267 · decided 1986-09-11
Clearance details
- K-number
- K863267
- Device name
- MAGNESIUM PROCEDURE
- Applicant
- Data Medical Associates, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1986-08-25
- Decision date
- 1986-09-11
- Days to decision
- 17 days
- Clearance type
- Traditional
- Product code
- CFA
- Device class
- 1
- Regulation number
- 862.1495
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Arlington, TX, 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 |
|---|---|---|
| ULTRA-VIOLET GLUCOSE REAGENT (K851514) | Bio-Analytics Laboratories, Inc. | 1985-05-20 |
Recalls involving this device
No recalls on record reference this clearance.