FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
TRIGLYCERIDE INSTRUMENT APPLICATION
K Number: K780172
·
Decision Mar 9, 1978
Classifications
1
FEI Numbers
45
Registration Numbers
45
Same Product Code
150
Applicant Total
116
Review Days
35
Basic Information
- Device Name
- TRIGLYCERIDE INSTRUMENT APPLICATION
- K Number
- K780172
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.1705
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- HARLECO
- Date Received
- February 2, 1978
- Decision Date
- March 9, 1978
- Product Code
- CDT
- 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 |
|---|---|---|---|
| CDT | Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides | FDA class 1 | Clinical Chemistry |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (CDT), ordered by most recent decision date.
Triglycerides
FDA 510(k)
FDA Class 1
·Clinical Chemistry
ADVIA CHEMISTRY TRIGLYCERIDES_2 (TRIG_2) REAGENT
FDA 510(k)
FDA Class 1
·Clinical Chemistry
VITROS CHEMISTRY PRODUCTS TRIG SLIDES
FDA 510(k)
FDA Class 1
·Clinical Chemistry
VANTERA CLINICAL ANALYZER
FDA 510(k)
FDA Class 1
·Clinical Chemistry
ELITECH CLINICAL SYSTEMS TRIGLYCERIDES SL, ELITECH CLINICAL SYSTEMS CHOLESTEROL SL
FDA 510(k)
FDA Class 1
·Clinical Chemistry
OLYMPUS TRIGLYCERIDE TEST SYSTEM
FDA 510(k)
FDA Class 1
·Clinical Chemistry
Other Clearances by HARLECO
| K Number | Device Name | ||
|---|---|---|---|
| K820233 | ULTRAZYME PLUS GAMMA GT(65055-65056) | Feb 12, 1982 | Substantially Equivalent |
| K813427 | ULTRACHEM GLUC-DH | Dec 31, 1981 | Substantially Equivalent |
| K813043 | ULTRACHEM CREA ITEM #64972 | Nov 10, 1981 | Substantially Equivalent |
| K813039 | ULTRACHEM E-CHOL, ITEM #65025 | Nov 10, 1981 | Substantially Equivalent |
| K813038 | ULTRACHEM TP, ITEM #64974 | Nov 10, 1981 | Substantially Equivalent |
| K813044 | ULTRACHEM ALB, ITEM #64970 | Nov 10, 1981 | Substantially Equivalent |
| K813042 | ULTRACHEM GLUC-DH SET, ITEM #65048 | Nov 10, 1981 | Substantially Equivalent |
| K813041 | ULTRAZYME-GT, ITEM #64959 & 65032 | Nov 10, 1981 | Substantially Equivalent |
| K813040 | ULTRACHEM CA, ITEM #64975 | Nov 10, 1981 | Substantially Equivalent |
| K812593 | ULTRA ZYME PLUS CK-1 #64978, 65027 & 28 | Oct 2, 1981 | Substantially Equivalent |