FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CLP 0.1 M SODIUM CITRATE SOLUTION
K Number: K880713
·
Decision Mar 18, 1988
Classifications
1
FEI Numbers
39
Registration Numbers
39
Same Product Code
180
Applicant Total
27
Review Days
25
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- CLP 0.1 M SODIUM CITRATE SOLUTION
- K Number
- K880713
- 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
- March 18, 1988
- Product Code
- JPA
- 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 |
|---|---|---|---|
| JPA | System, Multipurpose For In Vitro Coagulation Studies | FDA class 2 | Hematology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (JPA), ordered by most recent decision date.
STA Satellite Max®
FDA 510(k)
FDA Class 2
·Hematology
Automated Blood Coagulation Analyzer CN-Series (CN-6000)
FDA 510(k)
FDA Class 2
·Hematology
TEG 6s Hemostasis System Citrated: K, KH, RT, FF Assay Cartridge
FDA 510(k)
FDA Class 2
·Hematology
TEG 6s Hemostasis System Citrated: K, KH, RT, FF Assay Cartridge
FDA 510(k)
FDA Class 2
·Hematology
Citrated: K, KH, RTH, FFH
FDA 510(k)
FDA Class 2
·Hematology
ACL TOP 970 CL
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 |