FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
JAS CARBON DIOXIDE LIQUID REAGENT
K Number: K012332
·
Decision Sep 6, 2001
Classifications
1
FEI Numbers
35
Registration Numbers
35
Same Product Code
85
Applicant Total
20
Review Days
45
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
- JAS CARBON DIOXIDE LIQUID REAGENT
- K Number
- K012332
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1160
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Jas Diagnostics, Inc.
- Date Received
- July 23, 2001
- Decision Date
- September 6, 2001
- 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 Jas Diagnostics, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K130915 | XL-200 CLINICAL CHEMISTRY ANALYZER, JAS GLUCOSE REAGENT, ISE REAGENT PACK | May 15, 2014 | Substantially Equivalent |
| K080623 | CHOLESTEROL OXIDASE JASE, AND GLYCEROL INASE TRIGLYCERIDES, MODEL NA | Nov 17, 2008 | Substantially Equivalent |
| K080618 | DIRECT HBA1C, FRUCTOSAMINE, GLUCOSE OXIDASE LIQUID | May 23, 2008 | Substantially Equivalent |
| K022519 | LDL CHOLESTEROL (AUTOMATED) | Sep 30, 2002 | Substantially Equivalent |
| K021671 | JAS HDL CHOLESTEROL (AUTOMATED) REAGENT | Jul 19, 2002 | Substantially Equivalent |
| K020454 | CHEMISTRY CALIBRATOR | Apr 8, 2002 | Substantially Equivalent |
| K020282 | JAS AMYLASE LIQUID REAGENT | Feb 28, 2002 | Substantially Equivalent |
| K013912 | CREATINE KINASE (CK-NAC) | Jan 18, 2002 | Substantially Equivalent |
| K013698 | AST (SGOT) | Dec 21, 2001 | Substantially Equivalent |
| K012038 | JAS URIC ACID LIQUID REAGENT | Aug 21, 2001 | Substantially Equivalent |