FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
MAGNESIUM PROCEDURE
K Number: K861668
·
Decision May 27, 1986
Classifications
1
FEI Numbers
44
Registration Numbers
44
Same Product Code
89
Applicant Total
111
Review Days
27
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- MAGNESIUM PROCEDURE
- K Number
- K861668
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.1495
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Data Medical Associates, Inc.
- Date Received
- April 30, 1986
- Decision Date
- May 27, 1986
- Product Code
- JGJ
- Advisory Committee
- Clinical Chemistry
- Review Advisory Committee
- CH
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| JGJ | Photometric Method, Magnesium | FDA class 1 | Clinical Chemistry |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (JGJ), ordered by most recent decision date.
Magnesium
FDA 510(k)
FDA Class 1
·Clinical Chemistry
Magnesium
FDA 510(k)
FDA Class 1
·Clinical Chemistry
Randox RX Daytona Plus Magnesium (MG)
FDA 510(k)
FDA Class 1
·Clinical Chemistry
Atellica CH Magnesium (Mg)
FDA 510(k)
FDA Class 1
·Clinical Chemistry
ACE MAGNESIUM REGENT
FDA 510(k)
FDA Class 1
·Clinical Chemistry
MAGNESIUM ASSAY
FDA 510(k)
FDA Class 1
·Clinical Chemistry
Other Clearances by Data Medical Associates, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K993098 | HDL-C/LDL-C CALIBRATOR, MODEL 1913-003 | Oct 8, 1999 | Substantially Equivalent |
| K971113 | DMA TRIGLYCERIDES PROCEDURES | May 29, 1997 | Substantially Equivalent |
| K961919 | DMA GAMMA GLUTAMYLTRANSFERASE (GGT) PROCEDURE | Jul 1, 1996 | Substantially Equivalent |
| K955302 | SERUM BICARBONATE/CARBON DIOXIDE | Feb 29, 1996 | Substantially Equivalent |
| K955796 | IRON CALIBRATOR & CALIBRATION VERIFICATION SET | Feb 29, 1996 | Substantially Equivalent |
| K955300 | TOTAL BILIRUBIN PROCEDURE | Dec 20, 1995 | Substantially Equivalent |
| K952437 | DMA GLUCOSE HEXOKINASE U.V. PROCEDURE | Oct 3, 1995 | Substantially Equivalent |
| K946161 | DMA TOTAL CHOLESTEROL PROCEDURE | Aug 23, 1995 | Substantially Equivalent |
| K946354 | DMA UNSATURATED IRON BINDING CAPACITY PROCEDURE | May 8, 1995 | Substantially Equivalent |
| K946355 | DMA ALBUMIN PROCEDURE | Mar 1, 1995 | Substantially Equivalent |