FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ACT TEST CATRIDGES FOR COAGUCHEK PRO SYSTEM, ACT CONTROLS FOR COAGUCHEK PRO SYSTEM
K Number: K992851
·
Decision Jan 14, 2000
Classifications
1
FEI Numbers
13
Registration Numbers
13
Same Product Code
23
Applicant Total
264
Review Days
143
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Basic Information
- Device Name
- ACT TEST CATRIDGES FOR COAGUCHEK PRO SYSTEM, ACT CONTROLS FOR COAGUCHEK PRO SYSTEM
- K Number
- K992851
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 864.7140
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Roche Diagnostics Corp.
- Date Received
- August 24, 1999
- Decision Date
- January 14, 2000
- Product Code
- JBP
- 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 |
|---|---|---|---|
| JBP | Activated Whole Blood Clotting Time | FDA class 2 | Hematology |
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|---|---|---|---|
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| 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 |