FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
IL TEST(TM) TRIGLYCERIDE
K Number: K931116
·
Decision Mar 28, 1994
Classifications
1
FEI Numbers
26
Registration Numbers
26
Same Product Code
21
Applicant Total
321
Review Days
389
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Basic Information
- Device Name
- IL TEST(TM) TRIGLYCERIDE
- K Number
- K931116
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.1705
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Instrumentation Laboratory CO
- Date Received
- March 4, 1993
- Decision Date
- March 28, 1994
- Product Code
- JGY
- Advisory Committee
- Clinical Chemistry
- Review Advisory Committee
- TX
- 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 |
|---|---|---|---|
| JGY | Colorimetric Method, Triglycerides | FDA class 1 | Clinical Chemistry |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (JGY), ordered by most recent decision date.
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TRIGLYCERIDES
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TRIGLYCERIDES REAGENT
FDA 510(k)
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·Clinical Chemistry
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