FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
TRIGLYCERIDE
K Number: K880238
·
Decision Mar 15, 1988
Classifications
1
FEI Numbers
39
Registration Numbers
39
Same Product Code
150
Applicant Total
20
Review Days
55
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Basic Information
- Device Name
- TRIGLYCERIDE
- K Number
- K880238
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.1705
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Tech-Neal Scientific, Inc.
- Date Received
- January 20, 1988
- Decision Date
- March 15, 1988
- 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.
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ADVIA CHEMISTRY TRIGLYCERIDES_2 (TRIG_2) REAGENT
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VITROS CHEMISTRY PRODUCTS TRIG SLIDES
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VANTERA CLINICAL ANALYZER
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ELITECH CLINICAL SYSTEMS TRIGLYCERIDES SL, ELITECH CLINICAL SYSTEMS CHOLESTEROL SL
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OLYMPUS TRIGLYCERIDE TEST SYSTEM
FDA 510(k)
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Other Clearances by Tech-Neal Scientific, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K882256 | MAGNESIUM REAGENT SET | Aug 8, 1988 | Substantially Equivalent |
| K882459 | DIAZO, COLORIMETRIC BILIRUBIN | Aug 2, 1988 | Substantially Equivalent |
| K881239 | GAMMA GLUTAMYL TRANSFERASE REAGENT SET | May 31, 1988 | Substantially Equivalent |
| K881241 | TOTAL BILIRUBIN REAGENT | May 27, 1988 | Substantially Equivalent |
| K880237 | CHOLESTEROL | Apr 28, 1988 | Substantially Equivalent |
| K881237 | CREATINE KINASE (CK) REAGENT SET | Apr 28, 1988 | Substantially Equivalent |
| K881240 | CHLORIDE REAGENT SET | Apr 28, 1988 | Substantially Equivalent |
| K880277 | URIC ACID REAGENT SET | Apr 18, 1988 | Substantially Equivalent |
| K880845 | CALCIUM REAGENT SET | Apr 5, 1988 | Substantially Equivalent |
| K880842 | LDH-L REAGENT SET | Apr 5, 1988 | Substantially Equivalent |