FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CLP NORMAL COAGULATION CONTROL
K Number: K880712
·
Decision May 6, 1988
Classifications
1
FEI Numbers
17
Registration Numbers
17
Same Product Code
19
Applicant Total
27
Review Days
74
Basic Information
- Device Name
- CLP NORMAL COAGULATION CONTROL
- K Number
- K880712
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 864.5425
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Applicant
- CREATIVE LABORATORY PRODUCTS, INC.
- Date Received
- February 22, 1988
- Decision Date
- May 6, 1988
- Product Code
- GIZ
- 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 |
|---|---|---|---|
| GIZ | Plasma, Control, Normal | FDA class 2 | Hematology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (GIZ), ordered by most recent decision date.
STASIS - I, II AND III; SERATHAN - A, B; INTRIN - EA, SI CALCIUM CHLORIDE 0.02M; FIBRINOGEN CONTROL-NORMAL, LOW
FDA 510(k)
FDA Class 2
·Hematology
DADE BEHRING HEPARIN CALIBRATOR AND CONTROLS
FDA 510(k)
FDA Class 2
·Hematology
CONTROL PLASMA N
FDA 510(k)
FDA Class 2
·Hematology
REFERENCE CHECK, CATALOG NUMBER-RCN-10
FDA 510(k)
FDA Class 2
·Hematology
ACCUCLOT CONTROL I, MODEL A4089
FDA 510(k)
FDA Class 2
·Hematology
CONTROL PLASMA N
FDA 510(k)
FDA Class 2
·Hematology
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 |