FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
CLP LOW LEVEL HDL CHOLESTEROL-LIPID CONTROL-II
K Number: K904989
·
Decision Jan 23, 1991
Classifications
1
FEI Numbers
127
Registration Numbers
127
Same Product Code
672
Applicant Total
27
Review Days
77
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Basic Information
- Device Name
- CLP LOW LEVEL HDL CHOLESTEROL-LIPID CONTROL-II
- K Number
- K904989
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.1660
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Creative Laboratory Products, Inc.
- Date Received
- November 7, 1990
- Decision Date
- January 23, 1991
- Product Code
- JJY
- 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 |
|---|---|---|---|
| JJY | Multi-Analyte Controls, All Kinds (Assayed) | FDA class 1 | Clinical Chemistry |
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Other Clearances by Creative Laboratory Products, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K950589 | CLP HIGH LEVEL HIGH DENSITY LIPO PROTEIN CHOLESTEROL CONTROL-HL | Mar 20, 1995 | Substantially Equivalent |
| K942284 | CLP TOTAL IRON AND UIBC/TIBC LINEARITY CONTROL SET | Aug 26, 1994 | Substantially Equivalent |
| K922995 | LIPID CONTROLS | Aug 12, 1992 | Substantially Equivalent |
| K913427 | SICKLE HEMOGLOBIN (HBA/S) CONTROL SET | Nov 19, 1991 | Substantially Equivalent |
| K913371 | TOTAL IRON AND UNSAT IRON BIND CAPAC/IRON BIND CAL | Nov 8, 1991 | Substantially Equivalent |
| K913585 | LIPASE LINEARITY CONTROL | Oct 21, 1991 | Substantially Equivalent |
| K913224 | LIPID LINEARITY CONTROLS | Sep 25, 1991 | Substantially Equivalent |
| K913496 | CHOLINESTERASE LINEARITY CONTROL | Sep 11, 1991 | Substantially Equivalent |
| K912823 | HIGH DENSITY LIPOPROTEIN CHOLESTEROL | Aug 16, 1991 | Substantially Equivalent |
| K912725 | TOTAL IRON & UNSAT IRON BIND CAP/IRON BIND CONTROL | Jul 30, 1991 | Substantially Equivalent |