FDA 510(k)
FDA class 1
Substantially Equivalent
🇨🇦 Canada
HDL UNI-PAKS (PTA), CATALOGUE NUMBER 215-51
K Number: K980770
·
Decision Apr 21, 1998
Classifications
1
FEI Numbers
39
Registration Numbers
39
Same Product Code
65
Applicant Total
66
Review Days
60
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Basic Information
- Device Name
- HDL UNI-PAKS (PTA), CATALOGUE NUMBER 215-51
- K Number
- K980770
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.1475
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Diagnostic Chemicals , Ltd.
- Date Received
- February 20, 1998
- Decision Date
- April 21, 1998
- Product Code
- LBR
- 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 |
|---|---|---|---|
| LBR | Ldl & Vldl Precipitation, Hdl | FDA class 1 | Clinical Chemistry |
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| K042330 | ACETAMINOPHEN-SL ASSAY | Jan 7, 2005 | Substantially Equivalent |
| K042329 | SALICYLATE-SL ASSAY | Dec 27, 2004 | Substantially Equivalent |
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