FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
TAS ANALYZER
K Number: K933092
·
Decision Nov 15, 1993
Classifications
1
FEI Numbers
18
Registration Numbers
18
Same Product Code
48
Applicant Total
8
Review Days
144
Basic Information
- Device Name
- TAS ANALYZER
- K Number
- K933092
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 864.5400
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- CARDIOVASCULAR DIAGNOSTIC SERVICES
- Date Received
- June 24, 1993
- Decision Date
- November 15, 1993
- Product Code
- GKP
- 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 |
|---|---|---|---|
| GKP | Instrument, Coagulation, Automated | FDA class 2 | Hematology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (GKP), ordered by most recent decision date.
ACL TOP Family 50 Series (ACL TOP 750; ACL TOP 750 CTS; ACL TOP 750 LAS; ACL TOP 550 CTS; ACL TOP 350 CTS)
FDA 510(k)
FDA Class 2
·Hematology
ACL TOP Family 70 Series
FDA 510(k)
FDA Class 2
·Hematology
ACL TOP (ACL TOP 700, ACL TOP 700 CTS, ACL TOP 700 LAS, ACL TOP 500 CTS, ACL TOP 300 CTS)
FDA 510(k)
FDA Class 2
·Hematology
ACL TOP FAMILY 50 SERIES: ACL TOP 350 CTS; ACL TOP 550 CTS; ACL TOP 750; ACL TOP 750 CTS; ACL TOP 750 LAS
FDA 510(k)
FDA Class 2
·Hematology
ACL TOP 700 LAS
FDA 510(k)
FDA Class 2
·Hematology
ACL TOP (WITH SYSTEM SOFTWARE V3.0.0)
FDA 510(k)
FDA Class 2
·Hematology
Other Clearances by CARDIOVASCULAR DIAGNOSTIC SERVICES
| K Number | Device Name | ||
|---|---|---|---|
| K955843 | TAS PTONE | Mar 18, 1996 | Substantially Equivalent |
| K904325 | COAG-1 PT-NC TEST CARD | Jan 25, 1991 | Substantially Equivalent |
| K903019 | MODIFIED COAG-1 PT TEST CARD | Aug 1, 1990 | Substantially Equivalent |
| K891015 | COAG-1 APTT TEST CARD | May 22, 1989 | Substantially Equivalent |
| K882456 | COAG-I PT TEST CARD | Aug 25, 1988 | Substantially Equivalent |
| K882444 | COAG-I ANALYZER, ALPHA MODEL | Aug 25, 1988 | Substantially Equivalent |
| K812304 | DORROS-SPRING PRESSURIZER | Oct 13, 1981 | Substantially Equivalent |