FDA 510(k)
FDA class 2
Substantially Equivalent
🇦🇺 Australia
TRACE TOTAL/DIRECT BILIRUBIN REAGENT
K Number: K911866
·
Decision Jul 17, 1991
Classifications
1
FEI Numbers
52
Registration Numbers
52
Same Product Code
233
Applicant Total
55
Review Days
82
Basic Information
- Device Name
- TRACE TOTAL/DIRECT BILIRUBIN REAGENT
- K Number
- K911866
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1110
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- TRACE SCIENTIFIC LTD.
- Date Received
- April 26, 1991
- Decision Date
- July 17, 1991
- Product Code
- CIG
- 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 |
|---|---|---|---|
| CIG | Diazo Colorimetry, Bilirubin | FDA class 2 | Clinical Chemistry |
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Other Clearances by TRACE SCIENTIFIC LTD.
| K Number | Device Name | ||
|---|---|---|---|
| K982121 | ENZYMATIC MITOCHONDRIAL ANTIBODY (M2) REAGENT | Sep 17, 1998 | Substantially Equivalent |
| K981123 | UREA | Apr 24, 1998 | Substantially Equivalent |
| K962890 | CHOLESTEROL-INCORPORATING DYNAMIC STAB TECH (DST) | Sep 27, 1996 | Substantially Equivalent |
| K961114 | AST INCORPORATING DST | May 23, 1996 | Substantially Equivalent |
| K961123 | ALT INCORPORATING DST | Apr 25, 1996 | Substantially Equivalent |
| 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 |
| K903897 | TRIGLYCERIDES REAGENT GPO 5 X CONC. | Oct 1, 1990 | Substantially Equivalent |