FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
DATA-TOPE SYSTEM DIGOXIN RIA
K Number: K760416
·
Decision Aug 23, 1976
Classifications
1
FEI Numbers
0
Registration Numbers
0
Same Product Code
4
Applicant Total
44
Review Days
14
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Basic Information
- Device Name
- DATA-TOPE SYSTEM DIGOXIN RIA
- K Number
- K760416
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.3320
- Medical Specialty
- Clinical Toxicology
- Decision
- Substantially Equivalent
- Applicant
- Dade, Baxter Travenol Diagnostics, Inc.
- Date Received
- August 9, 1976
- Decision Date
- August 23, 1976
- Product Code
- DOG
- Advisory Committee
- Clinical Toxicology
- Review Advisory Committee
- TX
- 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 |
|---|---|---|---|
| DOG | Radioimmunoassay, Digoxin (125-I), Rabbit Antibody, Polyethylene Glycol | FDA class 2 | Clinical Toxicology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (DOG), ordered by most recent decision date.
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IMMU-TRACE DIGOXIN (125I) RADIOIMMUN.
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DIGOXIN RIA (PEG) KIT
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EMIT DIGOKIN ASSAY
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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 |