510(k) K863267
- Device
- MAGNESIUM PROCEDURE
- Applicant
- DATA MEDICAL ASSOCIATES, INC.
- 510(k) number
- K863267
- Product code
- CFA
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1986-09-11
- Date received
- 1986-08-25
- Regulation
- 862.1495
- Classification name
- Electrode, Ion Specific, Magnesium
- Medical specialty
- Clinical Chemistry
- Review panel
- Clinical Chemistry
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- MARJORIE B POTTS
- Address
- 845 Ave. G E. Arlington TX US 76011 76011
FDA Registration Numbers#
- 1219029
- 3023162659
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code CFA #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K851514 | ULTRA-VIOLET GLUCOSE REAGENT | Bio-Analytics Laboratories, Inc. | 1985-05-20 |
Legacy Summary#
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FDA Review#
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