FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
TRIGLYCERIDE (GPO) REAGENT, UNIVERSAL
K Number: K905226
·
Decision Dec 11, 1990
Classifications
1
FEI Numbers
29
Registration Numbers
29
Same Product Code
21
Applicant Total
5
Review Days
21
Basic Information
- Device Name
- TRIGLYCERIDE (GPO) REAGENT, UNIVERSAL
- K Number
- K905226
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.1705
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- ENZYME TECHNOLOGY, INC.
- Date Received
- November 20, 1990
- Decision Date
- December 11, 1990
- Product Code
- JGY
- 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 |
|---|---|---|---|
| JGY | Colorimetric Method, Triglycerides | FDA class 1 | Clinical Chemistry |
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Other Clearances by ENZYME TECHNOLOGY, INC.
| K Number | Device Name | ||
|---|---|---|---|
| K912027 | CALCIUM (ARSENAZO III) REAGENT, UNIVERSAL | Jan 30, 1992 | Substantially Equivalent |
| K912028 | URIC ACID (URICASE) REAGENT, UNIVERSAL | Dec 18, 1991 | Substantially Equivalent |
| K905227 | GLUCOSE (HK) REAGENT, UNIVERSAL | Mar 11, 1991 | Substantially Equivalent |
| K896073 | CHOLESTEROL, UNIVERSAL ET | Dec 12, 1989 | Substantially Equivalent |