FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
HMS PURPLE AND BLACK HEPARIN CARTRIDGES & CONTROL
K Number: K922031
·
Decision Jul 21, 1992
Classifications
1
FEI Numbers
3
Registration Numbers
3
Same Product Code
14
Applicant Total
5
Review Days
81
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Basic Information
- Device Name
- HMS PURPLE AND BLACK HEPARIN CARTRIDGES & CONTROL
- K Number
- K922031
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 864.5680
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Medtronic Hemotec, Inc.
- Date Received
- May 1, 1992
- Decision Date
- July 21, 1992
- Product Code
- JOX
- 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 |
|---|---|---|---|
| JOX | Analyzer, Heparin, Automated | FDA class 2 | Hematology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (JOX), ordered by most recent decision date.
HEMOSTASIS MANAGMENT SYSTEM PLUS (HMS-PLUS)
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HEPARIN DOSE RESPONSE CARTRIDGE
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FDA Class 2
·Hematology
HEMOSTASIS MANAGEMENT SYSTEM PLUS (HMS PLUS ), MODEL 305 XX
FDA 510(k)
FDA Class 2
·Hematology
HEPARIN DOSE RESPONSE CONTROLS, MODEL 306-20 POR
FDA 510(k)
FDA Class 2
·Hematology
HEPARIN DOSE RESPONSE CONTROLS, MODEL 306-20 POR
FDA 510(k)
FDA Class 2
·Hematology
HEPARIN DOSE RESPONSE CARTRIDGE, MODEL 304-20
FDA 510(k)
FDA Class 2
·Hematology
Other Clearances by Medtronic Hemotec, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K954202 | PLATELET FUNCTION TEST ASSAY CARTRIDGES FOR THE HEPCON HMS | Jun 20, 1996 | Substantially Equivalent |
| K944115 | HEPARIN ASSAY CARTRIDGES AND CONTROLS | Mar 24, 1995 | Substantially Equivalent |
| K940426 | MEDTRONIC HEMOTEC ACT II AUTOMATED COAGULATION TIMER | Sep 20, 1994 | Substantially Equivalent |
| K923594 | CLOTTRAC COAGULATION CONTROL | Sep 21, 1992 | Substantially Equivalent |