FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
STA COMPACT AUTOMATED MULTI-PARAMETRIC ANALYZER
K Number: K961579
·
Decision Jul 10, 1996
Classifications
1
FEI Numbers
17
Registration Numbers
17
Same Product Code
48
Applicant Total
79
Review Days
77
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Basic Information
- Device Name
- STA COMPACT AUTOMATED MULTI-PARAMETRIC ANALYZER
- K Number
- K961579
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 864.5400
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- American Bioproducts Co.
- Date Received
- April 24, 1996
- Decision Date
- July 10, 1996
- 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 American Bioproducts Co.
| K Number | Device Name | ||
|---|---|---|---|
| K983460 | STAR AUTOMATED MULTI-PARAMETRIC ANALYZER | Nov 12, 1998 | Substantially Equivalent |
| K971519 | ASSERACHROM TPA TEST KIT | Aug 19, 1997 | Substantially Equivalent |
| K964716 | STA LIATEST CONTROL [N]+[P] KIT | Jun 26, 1997 | Substantially Equivalent |
| K964728 | STA-LIATEST D-DI TEST KIT | Jun 26, 1997 | Substantially Equivalent |
| K964718 | STA D-DI CALIBRATOR KIT | May 23, 1997 | Substantially Equivalent |
| K962675 | STA - LIATEST VWF TEST KIT | Oct 25, 1996 | Substantially Equivalent |
| K962671 | STA-VWF CALIBRATOR KIT | Sep 13, 1996 | Substantially Equivalent |
| K962674 | STA - VWF CONTROL [N]+[P] KIT | Jul 23, 1996 | Substantially Equivalent |
| K955040 | AT-III CONTROL PLASMA KIT | Jan 31, 1996 | Substantially Equivalent |
| K954040 | ASSERACHROM TOTAL PROTEIN S KIT | Nov 13, 1995 | Substantially Equivalent |