FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
COAGUCHEK S SYSTEM, MODEL 2138280
K Number: K994349
·
Decision Sep 6, 2000
Classifications
1
FEI Numbers
39
Registration Numbers
39
Same Product Code
180
Applicant Total
264
Review Days
258
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 S SYSTEM, MODEL 2138280
- K Number
- K994349
- 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 Corp.
- Date Received
- December 23, 1999
- Decision Date
- September 6, 2000
- 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 Roche Diagnostics Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K130138 | SUPER SANI-CLOTH/ ACCU-CHEK INFORM II SYSTEM | Mar 15, 2013 | Substantially Equivalent |
| K101365 | ELECSYS CA 19-9 CALCHECK 5 | Oct 5, 2010 | Substantially Equivalent |
| K100853 | COBAS 8000 MODULAR SERIES ANALYZER | Sep 9, 2010 | Substantially Equivalent |
| K101196 | ACCU-CHEK ULTRFLEX INFUSION SET | Aug 27, 2010 | Substantially Equivalent |
| K093664 | AMPHETAMINES II ASSAY | Jul 28, 2010 | Substantially Equivalent |
| K101075 | ELECSYS INSULIN CALCHECK 5 | Jun 11, 2010 | Substantially Equivalent |
| K093421 | ELECSYS TESTOSTERONE II IMMUNOASSAY | Apr 23, 2010 | Substantially Equivalent |
| K092848 | ELECSYS TROPONIN T CALCHECK 5 | Mar 19, 2010 | Substantially Equivalent |
| K092940 | COAGUCHEK XS PLUS PST SYSTEM | Mar 5, 2010 | Substantially Equivalent |
| K093700 | ELECSYS HCG STAT CALCHECK 5 | Mar 4, 2010 | Substantially Equivalent |