FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
COAG-A-MATE(R) XM
K Number: K881281
·
Decision May 18, 1988
Classifications
1
FEI Numbers
17
Registration Numbers
17
Same Product Code
48
Applicant Total
130
Review Days
54
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Basic Information
- Device Name
- COAG-A-MATE(R) XM
- K Number
- K881281
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 864.5400
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Applicant
- Organon Teknika Corp.
- Date Received
- March 25, 1988
- Decision Date
- May 18, 1988
- 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.
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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
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ACL TOP 700 LAS
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ACL TOP (WITH SYSTEM SOFTWARE V3.0.0)
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