FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
AMMONIA REAGENT
K Number: K821719
·
Decision Jun 24, 1982
Classifications
1
FEI Numbers
19
Registration Numbers
19
Same Product Code
29
Applicant Total
50
Review Days
14
Basic Information
- Device Name
- AMMONIA REAGENT
- K Number
- K821719
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.1065
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- GILFORD DIAGNOSTICS
- Date Received
- June 10, 1982
- Decision Date
- June 24, 1982
- Product Code
- JIF
- Advisory Committee
- Clinical Chemistry
- Review Advisory Committee
- MI
- 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 |
|---|---|---|---|
| JIF | Enzymatic Method, Ammonia | FDA class 1 | Clinical Chemistry |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (JIF), ordered by most recent decision date.
Ammonia II
FDA 510(k)
FDA Class 1
·Clinical Chemistry
DIMENSION VISTA; AMMONIA FLEX REAGENT CARTRIDGE (AMM), CHEMISTRY 3 CALIBRATOR (CHEM 3 CAL)
FDA 510(k)
FDA Class 1
·Clinical Chemistry
DIMENSION AMMONIA FLEX REAGENT CARTRIDGE
FDA 510(k)
FDA Class 1
·Clinical Chemistry
DIMENSION VISTA AMMONIA (AMON) FLEX REAGENT CARTRIDGE
FDA 510(k)
FDA Class 1
·Clinical Chemistry
SENTINEL AMMONIA ULTRA DIAGNOSTIC ASSAY
FDA 510(k)
FDA Class 1
·Clinical Chemistry
AMMONIA-L3K ASSAY, CATALOGUE NUMBER 233-10
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 |
| K831843 | GILCHEM TOTAL BILIRUBIN REAGENT | Jul 18, 1983 | Substantially Equivalent |
| K831844 | DIRECT 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 |
| K820975 | GILCHEM ACID PHOSPHATASE REAGENT | Apr 26, 1982 | Substantially Equivalent |
| K820976 | GIL CHEM MAGNESIUM REAGENT | Apr 26, 1982 | Substantially Equivalent |