FDA 510(k)
FDA class 2
Substantially Equivalent
🇦🇺 Australia
UREA
K Number: K981123
·
Decision Apr 24, 1998
Classifications
1
FEI Numbers
42
Registration Numbers
42
Same Product Code
116
Applicant Total
55
Review Days
28
Basic Information
- Device Name
- UREA
- K Number
- K981123
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1770
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- TRACE SCIENTIFIC LTD.
- Date Received
- March 27, 1998
- Decision Date
- April 24, 1998
- Product Code
- CDQ
- 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 |
|---|---|---|---|
| CDQ | Urease And Glutamic Dehydrogenase, Urea Nitrogen | FDA class 2 | Clinical Chemistry |
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|---|---|---|---|
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| K952488 | TRACE COBAS MIRA RANGE | Oct 13, 1995 | Substantially Equivalent |
| K932713 | TRACE TRANSFERRIN REAGENT | Sep 30, 1993 | Substantially Equivalent |
| K923322 | TRACE ALBUMIN-MR REAGENT | Sep 11, 1992 | Substantially Equivalent |
| K914731 | TRACE GAMMA GT-SS REAGENT | Nov 19, 1991 | Substantially Equivalent |
| K911866 | TRACE TOTAL/DIRECT BILIRUBIN REAGENT | Jul 17, 1991 | Substantially Equivalent |
| K903897 | TRIGLYCERIDES REAGENT GPO 5 X CONC. | Oct 1, 1990 | Substantially Equivalent |