FDA 510(k)
Substantially Equivalent
🇺🇸 United States
CARDIOZYME CK-MB REAGENTS
K Number: K770974
·
Decision Aug 26, 1977
Classifications
0
FEI Numbers
0
Registration Numbers
0
Same Product Code
0
Applicant Total
44
Review Days
87
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Basic Information
- Device Name
- CARDIOZYME CK-MB REAGENTS
- K Number
- K770974
- Clearance Type
- Traditional
- Decision
- Substantially Equivalent
- Applicant
- Dade, Baxter Travenol Diagnostics, Inc.
- Date Received
- May 31, 1977
- Decision Date
- August 26, 1977
- Advisory Committee
- Unknown
- Review Advisory Committee
- CH
- Third Party
- N
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 |