FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CEA CONTROL PLASMA
K Number: K812658
·
Decision Sep 29, 1981
Classifications
1
FEI Numbers
27
Registration Numbers
27
Same Product Code
27
Applicant Total
29
Review Days
11
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Basic Information
- Device Name
- CEA CONTROL PLASMA
- K Number
- K812658
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.6010
- Medical Specialty
- Immunology
- Decision
- Substantially Equivalent
- Applicant
- Pacific Hemostasis
- Date Received
- September 18, 1981
- Decision Date
- September 29, 1981
- Product Code
- DHX
- Advisory Committee
- Immunology
- Review Advisory Committee
- IM
- 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 |
|---|---|---|---|
| DHX | System, Test, Carcinoembryonic Antigen | FDA class 2 | Immunology |
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Other Clearances by Pacific Hemostasis
| K Number | Device Name | ||
|---|---|---|---|
| K000679 | THROMBOSTRATE CONTROL PLASMAS | Mar 24, 2000 | Substantially Equivalent |
| 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 |
| K984130 | COAGULATION CONTROL LEVEL 2 (ABNORMAL) | Dec 1, 1998 | Substantially Equivalent |
| K984129 | COAGULATION CONTROL LEVEL 1 (NORMAL) | Dec 1, 1998 | Substantially Equivalent |
| K984131 | COAGULATION CONTROL LEVEL 3 (ABNORMAL) | Dec 1, 1998 | Substantially Equivalent |