FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
GIL CHEM MAGNESIUM REAGENT
K Number: K820976
·
Decision Apr 26, 1982
Classifications
1
FEI Numbers
44
Registration Numbers
44
Same Product Code
89
Applicant Total
50
Review Days
20
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
- GIL CHEM MAGNESIUM REAGENT
- K Number
- K820976
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.1495
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Gilford Diagnostics
- Date Received
- April 6, 1982
- Decision Date
- April 26, 1982
- 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 Gilford Diagnostics
| K Number | Device Name | ||
|---|---|---|---|
| K832094 | BILIRUBIN CALIBRATORS & CONTROL | Aug 11, 1983 | Substantially Equivalent |
| K831844 | DIRECT BILIRUBIN REAGENT | Jul 18, 1983 | Substantially Equivalent |
| K831843 | GILCHEM TOTAL BILIRUBIN REAGENT | Jul 18, 1983 | Substantially Equivalent |
| K823709 | TRIGLYCERIDE REAGENT (UV) | Jan 7, 1983 | Substantially Equivalent |
| K822739 | AHBD | Oct 18, 1982 | Substantially Equivalent |
| K822334 | BILIRUBIN CALIBRATORS | Sep 2, 1982 | Substantially Equivalent |
| K822289 | CO2/CI STANDARDS | Aug 24, 1982 | Substantially Equivalent |
| K822149 | GILCHEM Y-GT REAGENT | Aug 12, 1982 | Substantially Equivalent |
| K821719 | AMMONIA REAGENT | Jun 24, 1982 | Substantially Equivalent |
| K820975 | GILCHEM ACID PHOSPHATASE REAGENT | Apr 26, 1982 | Substantially Equivalent |