FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
URIC ACID - INCORPORATING DYNAMIC STABILIZATION TECHNOLOGY - (DST)
K Number: K971485
·
Decision May 27, 1997
Classifications
1
FEI Numbers
5
Registration Numbers
5
Same Product Code
30
Applicant Total
22
Review Days
34
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Basic Information
- Device Name
- URIC ACID - INCORPORATING DYNAMIC STABILIZATION TECHNOLOGY - (DST)
- K Number
- K971485
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.1775
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Trace America, Inc.
- Date Received
- April 23, 1997
- Decision Date
- May 27, 1997
- Product Code
- CDO
- 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 |
|---|---|---|---|
| CDO | Acid, Uric, Uricase (U.V.) | FDA class 1 | Clinical Chemistry |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (CDO), ordered by most recent decision date.
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OLYMPUS URIC ACID REAGENT
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Other Clearances by Trace America, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K003583 | LITHIUM REGENT MODEL TR66056 / LITHIUM STANDARD TR66901 | Jan 17, 2001 | Substantially Equivalent |
| K980026 | GLUCOSE (HK) - INCORPORATING DYNAMIC STABILIZATION TECHNOLOGY - (DST) | Mar 10, 1998 | Substantially Equivalent |
| K980028 | ALT (GPT) LIQUID STABLE 2 VIAL - INCORPORATING DYNAMIC STABILIZATION TECHNOLOGY - (DST) | Feb 2, 1998 | Substantially Equivalent |
| K980030 | AST )GOT) LIQUID STABLE 2 VIAL - INCORPORATING DYNAMIC STABILIZATION TECHNOLOGY - (DST) | Jan 30, 1998 | Substantially Equivalent |
| K973869 | TRACE REAGENT LINE FOR THE COBAS MIRA | Jan 7, 1998 | Substantially Equivalent |
| K974620 | AMMONIA-INCORPORATING DYNAMIC STABILIZATION TECHNOLOGY (DST) | Jan 2, 1998 | Substantially Equivalent |
| K972297 | AMYLASE-INCORPORATING DYNAMIC STABILIZATION TECHNOLOGY - (DST) | Jul 17, 1997 | Substantially Equivalent |
| K971477 | UREA (UREA NITROGEN) - INCORPORATING DYNAMIC STABILIZATION TECHNOLOGY (DST) | May 27, 1997 | Substantially Equivalent |
| K962723 | TRACE HDL CHOLESTEROL - AUTOMATED (HOMOGEN | Mar 13, 1997 | Substantially Equivalent |
| K961984 | PORPHOBILINOGEN (PBG) | Dec 10, 1996 | Substantially Equivalent |