FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
COAGULATION CONTROL PLASMA(ABNORMAL)LEVEL 0
K Number: K971428
·
Decision Jun 17, 1997
Classifications
1
FEI Numbers
44
Registration Numbers
44
Same Product Code
98
Applicant Total
29
Review Days
61
Basic Information
- Device Name
- COAGULATION CONTROL PLASMA(ABNORMAL)LEVEL 0
- K Number
- K971428
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 864.5425
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- PACIFIC HEMOSTASIS
- Date Received
- April 17, 1997
- Decision Date
- June 17, 1997
- Product Code
- GGN
- 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 |
|---|---|---|---|
| GGN | Plasma, Coagulation Control | FDA class 2 | Hematology |
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Other Clearances by PACIFIC HEMOSTASIS
| K Number | Device Name | ||
|---|---|---|---|
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| K994100 | PACIFIC HEMOSTASIS THROMBOPLASTIN D | Feb 18, 2000 | Substantially Equivalent |
| K992130 | PACIFIC HEMOSTASIS THROMBOSCREEN 400C | Sep 3, 1999 | Substantially Equivalent |
| K992279 | HEPARIN CONTROL PLASMA LEVEL 2 | Aug 26, 1999 | Substantially Equivalent |
| K992278 | HEPARIN CONTROL PLASMA LEVEL 1 | Aug 26, 1999 | Substantially Equivalent |
| K991321 | PACIFIC HEMOSTASIS THROMBOSCREEN 200 | Jun 21, 1999 | Substantially Equivalent |
| K990046 | PACIFIC HEMOSTASIS IMMUNODEPLETED FACTOR VIII DEFICIENT PLASMA | Feb 17, 1999 | Substantially Equivalent |
| K984131 | COAGULATION CONTROL LEVEL 3 (ABNORMAL) | Dec 1, 1998 | Substantially Equivalent |
| K984130 | COAGULATION CONTROL LEVEL 2 (ABNORMAL) | Dec 1, 1998 | Substantially Equivalent |
| K984129 | COAGULATION CONTROL LEVEL 1 (NORMAL) | Dec 1, 1998 | Substantially Equivalent |