FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
LITHIUM DILUENT (1500 MM/E)
K Number: K800039
·
Decision Jan 21, 1980
Classifications
1
FEI Numbers
15
Registration Numbers
15
Same Product Code
11
Applicant Total
50
Review Days
14
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Basic Information
- Device Name
- LITHIUM DILUENT (1500 MM/E)
- K Number
- K800039
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.3560
- Medical Specialty
- Clinical Toxicology
- Decision
- Substantially Equivalent
- Applicant
- Gilford Diagnostics
- Date Received
- January 7, 1980
- Decision Date
- January 21, 1980
- Product Code
- JIH
- Advisory Committee
- Clinical Toxicology
- 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 |
|---|---|---|---|
| JIH | Flame Photometry, Lithium | FDA class 2 | Clinical Toxicology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (JIH), ordered by most recent decision date.
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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 |
| K820976 | GIL CHEM MAGNESIUM REAGENT | Apr 26, 1982 | Substantially Equivalent |