FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
PLASMINOGEN ASSAY
K Number: K781478
·
Decision Nov 15, 1978
Classifications
1
FEI Numbers
6
Registration Numbers
6
Same Product Code
9
Applicant Total
44
Review Days
79
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Basic Information
- Device Name
- PLASMINOGEN ASSAY
- K Number
- K781478
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 866.5715
- Medical Specialty
- Immunology
- Decision
- Substantially Equivalent
- Applicant
- Dade, Baxter Travenol Diagnostics, Inc.
- Date Received
- August 28, 1978
- Decision Date
- November 15, 1978
- Product Code
- DDX
- 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 |
|---|---|---|---|
| DDX | Plasminogen, Antigen, Antiserum, Control | FDA class 1 | Immunology |
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Other Clearances by Dade, Baxter Travenol Diagnostics, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K800296 | WHOLE BLOOD GAS CONTROL, LEVELS 1,2,&3 | Mar 5, 1980 | Substantially Equivalent |
| K792606 | WHOLE BLOOD PLATELET CONTROL NORMAL, | Feb 13, 1980 | Substantially Equivalent |
| K792723 | BLOOD FLUID FILTERS | Jan 21, 1980 | Substantially Equivalent |
| K792607 | T3 UPTAKE (T3U) REAGENTS | Jan 16, 1980 | Substantially Equivalent |
| K792443 | TSH RADIOIMMUNOASSAY | Dec 27, 1979 | Substantially Equivalent |
| K792442 | FERRITIN RADIOIMMUNOASSAY | Dec 18, 1979 | Substantially Equivalent |
| K791922 | HARLECO BRAND CLINICARD LIPASE TEST SET | Nov 27, 1979 | Substantially Equivalent |
| K792183 | DADE HIGH DENSITY LIPOPROTEIN CHOLESTERO | Nov 13, 1979 | Substantially Equivalent |
| K790767 | IMMU-TEK AUTOMATIC CENTRIFUGE | May 23, 1979 | Substantially Equivalent |
| K790776 | DADE LOW IONIC STRENGTH SOLUITION (LISS) | May 23, 1979 | Substantially Equivalent |