FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
MULTI-ENZYME LINEARITY SOLUTION
K Number: K880266
·
Decision Feb 18, 1988
Classifications
1
FEI Numbers
16
Registration Numbers
16
Same Product Code
96
Applicant Total
14
Review Days
27
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Basic Information
- Device Name
- MULTI-ENZYME LINEARITY SOLUTION
- K Number
- K880266
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.1660
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Verichem Laboratories, Inc.
- Date Received
- January 22, 1988
- Decision Date
- February 18, 1988
- Product Code
- JJT
- 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 |
|---|---|---|---|
| JJT | Enzyme Controls (Assayed And Unassayed) | FDA class 1 | Clinical Chemistry |
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Other Clearances by Verichem Laboratories, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K112834 | MULTI-CHEMISTRY STANDARD KIT, URIC ACID STANDARD KIT, URINE CHEMISTRY STARDAND KIT, URINE URIC ACID STANDARD KIT, CHOLES | Mar 28, 2012 | Substantially Equivalent |
| K974290 | MICROPROTEIN STANDARD KIT | Dec 19, 1997 | Substantially Equivalent |
| K973345 | MATRIX PLUS MULTI-CALIBRATOR KIT | Oct 29, 1997 | Substantially Equivalent |
| K972333 | AMMONIA/IRON STANDARD KIT | Jul 23, 1997 | Substantially Equivalent |
| K924904 | HDL-CHOLESTEROL STANDARD, MODIFICATION | Jan 13, 1993 | Substantially Equivalent |
| K912513 | ELECTROLYTE CONTROL | Jul 19, 1991 | Substantially Equivalent |
| K901113 | MATRIX PLUS(TM) CHEMISTRY REFERENCE STANDARD | Mar 29, 1990 | Substantially Equivalent |
| K882059 | BILIRUBIN STANDARD | Oct 25, 1988 | Substantially Equivalent |
| K881320 | URINE TOXICOLOGY STANDARD | Sep 9, 1988 | Substantially Equivalent |
| K875285 | MULTI-CHEMISTRY LINEARITY STANDARD | Sep 2, 1988 | Substantially Equivalent |