510(k) K851514
- Device
- ULTRA-VIOLET GLUCOSE REAGENT
- Applicant
- BIO-ANALYTICS LABORATORIES, INC.
- 510(k) number
- K851514
- Product code
- CFA
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1985-05-20
- Date received
- 1985-04-15
- 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
- ROY
- Address
- One Bio-Analytics Pl. Box 333 Palm City FL US 33490 33490
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 |
|---|---|---|---|
| K863267 | MAGNESIUM PROCEDURE | Data Medical Associates, Inc. | 1986-09-11 |
Legacy Summary#
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FDA Review#
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