FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MICROSAMPLE COAGULATION ANALYZER, MODEL MCA 310-C
K Number: K001891
·
Decision Jul 12, 2000
Classifications
1
FEI Numbers
17
Registration Numbers
17
Same Product Code
48
Applicant Total
37
Review Days
21
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Basic Information
- Device Name
- MICROSAMPLE COAGULATION ANALYZER, MODEL MCA 310-C
- K Number
- K001891
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 864.5400
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Bio/Data Corp.
- Date Received
- June 21, 2000
- Decision Date
- July 12, 2000
- 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)
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ACL TOP (ACL TOP 700, ACL TOP 700 CTS, ACL TOP 700 LAS, ACL TOP 500 CTS, ACL TOP 300 CTS)
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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)
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·Hematology
Other Clearances by Bio/Data Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K943153 | MICROSAMPLE COAGULATION ANALYZER | Mar 24, 1995 | Substantially Equivalent |
| K893650 | PLATELET AGGREGATION PROFILER MODEL PAP-4C | Jun 23, 1989 | Substantially Equivalent |
| K881150 | KINETIC FIBRINOGEN ASSAY | Mar 28, 1988 | Substantially Equivalent |
| K873382 | PLATELET EXTRACT REAGENT | Nov 20, 1987 | Substantially Equivalent |
| K860751 | VON WILLEBRAND FAC. DEFIC. ABNORMAL CONTROL PLASMA | Mar 18, 1986 | Substantially Equivalent |
| K860342 | MICROSAMPLE COAGULATION ANALYSER, MODEL 110WP | Mar 4, 1986 | Substantially Equivalent |
| K854546 | MICROSAMPLE COAGULATION ANALYSER MODEL 110P | Jan 7, 1986 | Substantially Equivalent |
| K853897 | CITREX H | Oct 10, 1985 | Substantially Equivalent |
| K853246 | CALCIUM CHLORIDE | Aug 13, 1985 | Substantially Equivalent |
| K853078 | CITREX III | Aug 12, 1985 | Substantially Equivalent |