FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
COAGUCHEK PRO SYSTEM, APTT TEST CARTRIDGES FOR COAGUCHEK PRO SYSTEM, APTT CONTROLS FOR COAGUCHEK PRO SYSTEM, COAGUCHEK P
K Number: K983892
·
Decision Apr 13, 1999
Classifications
1
FEI Numbers
39
Registration Numbers
39
Same Product Code
180
Applicant Total
3
Review Days
161
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
- COAGUCHEK PRO SYSTEM, APTT TEST CARTRIDGES FOR COAGUCHEK PRO SYSTEM, APTT CONTROLS FOR COAGUCHEK PRO SYSTEM, COAGUCHEK P
- K Number
- K983892
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 864.5425
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Roche Diagnostics/Boehringer Mannheim GmbH
- Date Received
- November 3, 1998
- Decision Date
- April 13, 1999
- 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