FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
HARLECO BRAND CLINICARD LIPASE TEST SET
K Number: K791922
·
Decision Nov 27, 1979
Classifications
1
FEI Numbers
8
Registration Numbers
8
Same Product Code
14
Applicant Total
44
Review Days
62
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Basic Information
- Device Name
- HARLECO BRAND CLINICARD LIPASE TEST SET
- K Number
- K791922
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.1465
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Dade, Baxter Travenol Diagnostics, Inc.
- Date Received
- September 26, 1979
- Decision Date
- November 27, 1979
- Product Code
- CET
- Advisory Committee
- Clinical Chemistry
- Review Advisory Committee
- CH
- 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 |
|---|---|---|---|
| CET | Olive Oil Emulsion (Turbidimetric), Lipase | FDA class 1 | Clinical Chemistry |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (CET), ordered by most recent decision date.
LIPASE REAGENT SET (COLIPASE METHOD)
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MODIFIED LABELING FOR ACA LIPASE ANALYTICAL TEST
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DELTATEST (R) LIPASE II
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LIPASE SR LIQUID STABLE REAGENT SET
FDA 510(k)
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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 |
| 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 |
| K790571 | QUIK-STAIN | Apr 23, 1979 | Substantially Equivalent |