FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
STAR AUTOMATED MULTI-PARAMETRIC ANALYZER
K Number: K983460
·
Decision Nov 12, 1998
Classifications
1
FEI Numbers
39
Registration Numbers
39
Same Product Code
180
Applicant Total
79
Review Days
43
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
- STAR AUTOMATED MULTI-PARAMETRIC ANALYZER
- K Number
- K983460
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 864.5425
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- American Bioproducts Co.
- Date Received
- September 30, 1998
- Decision Date
- November 12, 1998
- 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 American Bioproducts Co.
| K Number | Device Name | ||
|---|---|---|---|
| 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 |
| K961579 | STA COMPACT AUTOMATED MULTI-PARAMETRIC ANALYZER | Jul 10, 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 |