FDA 510(k)
FDA class 2
Substantially Equivalent
🇦🇺 Australia
BICARBONATE (CO2) REAGENT-2 VIAL
K Number: K881938
·
Decision Jun 15, 1988
Classifications
1
FEI Numbers
35
Registration Numbers
35
Same Product Code
85
Applicant Total
55
Review Days
37
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Basic Information
- Device Name
- BICARBONATE (CO2) REAGENT-2 VIAL
- K Number
- K881938
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1160
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Trace Scientific , Ltd.
- Date Received
- May 9, 1988
- Decision Date
- June 15, 1988
- Product Code
- KHS
- 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 |
|---|---|---|---|
| KHS | Enzymatic, Carbon-Dioxide | 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 |
| K911866 | TRACE TOTAL/DIRECT BILIRUBIN REAGENT | Jul 17, 1991 | Substantially Equivalent |