FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
POSITIVE LUPUS ANTICOAGULANT PLASMA
K Number: K945856
·
Decision Oct 5, 1995
Classifications
1
FEI Numbers
18
Registration Numbers
18
Same Product Code
39
Applicant Total
5
Review Days
325
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Basic Information
- Device Name
- POSITIVE LUPUS ANTICOAGULANT PLASMA
- K Number
- K945856
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 864.5425
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- George King Bio-Medical, Inc.
- Date Received
- November 14, 1994
- Decision Date
- October 5, 1995
- Product Code
- GGC
- 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 |
|---|---|---|---|
| GGC | Control, Plasma, Abnormal | FDA class 2 | Hematology |
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Other Clearances by George King Bio-Medical, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K161316 | George King Coumadin Plasma | Feb 23, 2017 | Substantially Equivalent |
| K945854 | B-FACT, BORDERLINE FACTOR ASSAY CONTROL | Oct 24, 1995 | Substantially Equivalent |
| K945855 | A-FACT, ABNORMAL FACTOR ASSAY CONTROL | Oct 24, 1995 | Substantially Equivalent |
| K945857 | PROTEIN C DEFICIENT PLASMA | Oct 20, 1995 | Substantially Equivalent |