FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SICKLE HEMOGLOBIN (HBA/S) CONTROL SET
K Number: K913427
·
Decision Nov 19, 1991
Classifications
1
FEI Numbers
6
Registration Numbers
6
Same Product Code
11
Applicant Total
27
Review Days
110
Basic Information
- Device Name
- SICKLE HEMOGLOBIN (HBA/S) CONTROL SET
- K Number
- K913427
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 864.7415
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- CREATIVE LABORATORY PRODUCTS, INC.
- Date Received
- August 1, 1991
- Decision Date
- November 19, 1991
- Product Code
- JCM
- Advisory Committee
- Hematology
- Review Advisory Committee
- HE
- 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 |
|---|---|---|---|
| JCM | Control, Hemoglobin, Abnormal | FDA class 2 | Hematology |
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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 |
| 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 |
| K904989 | CLP LOW LEVEL HDL CHOLESTEROL-LIPID CONTROL-II | Jan 23, 1991 | Substantially Equivalent |