FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
LIPASE
K Number: K771903
·
Decision Dec 6, 1977
Classifications
1
FEI Numbers
39
Registration Numbers
39
Same Product Code
150
Applicant Total
14
Review Days
60
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Basic Information
- Device Name
- LIPASE
- K Number
- K771903
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.1705
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Simmler & Son, Inc.
- Date Received
- October 7, 1977
- Decision Date
- December 6, 1977
- 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
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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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FDA Class 1
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OLYMPUS TRIGLYCERIDE TEST SYSTEM
FDA 510(k)
FDA Class 1
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Other Clearances by Simmler & Son, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K780817 | GLOBIN-TERGE | Jul 27, 1978 | Substantially Equivalent |
| K771906 | PHOSPHATE | Dec 6, 1977 | Substantially Equivalent |
| K771905 | GLYCEROL SUBSTRATE | Dec 6, 1977 | Substantially Equivalent |
| K771904 | GLYCEROL KINASE | Dec 6, 1977 | Substantially Equivalent |
| K761086 | REAGENTS | Jan 12, 1977 | Substantially Equivalent |
| K760476 | REAGENT, LACTATE DEHYDROGENASE | Nov 1, 1976 | Substantially Equivalent |
| K760473 | REAGENT, ALBUMIN DETERMINATION | Oct 29, 1976 | Substantially Equivalent |
| K760478 | REAGENT, BUN (UREA NITROGEN) DETERM. | Oct 29, 1976 | Substantially Equivalent |
| K760474 | REAGENT, ALKALINE PHOSPHATASE DETERM. | Oct 29, 1976 | Substantially Equivalent |
| K760480 | REAGENT, TOTAL PROTEIN DETERMINATION | Oct 29, 1976 | Substantially Equivalent |