FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CARBON DIOXIDE - DST
K Number: K952410
·
Decision Oct 5, 1995
Classifications
1
FEI Numbers
35
Registration Numbers
35
Same Product Code
85
Applicant Total
22
Review Days
134
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- CARBON DIOXIDE - DST
- K Number
- K952410
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1160
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Trace America, Inc.
- Date Received
- May 24, 1995
- Decision Date
- October 5, 1995
- 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 |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (KHS), ordered by most recent decision date.
Carbon Dioxide Reagent Set
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Liquid CO2-2 (LCO2-2)
FDA 510(k)
FDA Class 2
·Clinical Chemistry
S TEST REAGENT CARTRIDGE CARBON DIOXIDE (CO2)
FDA 510(k)
FDA Class 2
·Clinical Chemistry
AU BICARBONATE REAGENT
FDA 510(k)
FDA Class 2
·Clinical Chemistry
ACE CARBON DIOXIDE REAGENT, ACE DIRECT BILIUBIN REAGENT, ACE TOTAL BILIRUBIN REAGENT, ACE MAGNESIUM REAGENT
FDA 510(k)
FDA Class 2
·Clinical Chemistry
VITROS CHEMISTRY PRODUCTS ECO2 SLIDES
FDA 510(k)
FDA Class 2
·Clinical Chemistry
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 |
| K971485 | URIC ACID - INCORPORATING DYNAMIC STABILIZATION TECHNOLOGY - (DST) | May 27, 1997 | Substantially Equivalent |
| K962723 | TRACE HDL CHOLESTEROL - AUTOMATED (HOMOGEN | Mar 13, 1997 | Substantially Equivalent |