FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
TRIGLYCERIDES TEST KIT
K Number: K781477
·
Decision Oct 3, 1978
Classifications
1
FEI Numbers
39
Registration Numbers
39
Same Product Code
150
Applicant Total
92
Review Days
36
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
- TRIGLYCERIDES TEST KIT
- K Number
- K781477
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.1705
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Mallinckrodt Critical Care
- Date Received
- August 28, 1978
- Decision Date
- October 3, 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 Mallinckrodt Critical Care
| K Number | Device Name | ||
|---|---|---|---|
| K880343 | BURNEY GALLBLADDER CATHETER KIT | May 1, 1989 | Substantially Equivalent |
| K874605 | HI-LO TEMP(R) MYOCARDIAL TEMPERATURE SENSOR | Feb 2, 1988 | Substantially Equivalent |
| K874514 | HI-LO TEMP(R) GENERAL PURPOSE TEMPERATURE PROBE | Jan 29, 1988 | Substantially Equivalent |
| K874568 | HI-LO TEMP(R) MODEL 8700 PATIENT TEMP MONITOR | Jan 6, 1988 | Substantially Equivalent |
| K874404 | HI-LO TEMP(R) SKIN TEMPERATURE SENSOR | Nov 6, 1987 | Substantially Equivalent |
| K873461 | LASER-FLEX(TM) TRACHEAL TUBE (CUFFED) | Nov 6, 1987 | Substantially Equivalent |
| K873833 | THERMOCOUPLE ADAPTER | Nov 3, 1987 | Substantially Equivalent |
| K873004 | GUIDING CATHETER | Sep 15, 1987 | Substantially Equivalent |
| K871204 | CUFFED TRACHEAL TUBE (MULTIPLE) | Apr 21, 1987 | Substantially Equivalent |
| K862666 | UNCUFFED LASER RESISTEANT TRACHEAL TUBE(TENTATIVE) | Aug 1, 1986 | Substantially Equivalent |