FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
JAS MAGNESIUM REAGENT
K Number: K003835
·
Decision Mar 23, 2001
Classifications
1
FEI Numbers
44
Registration Numbers
44
Same Product Code
89
Applicant Total
20
Review Days
101
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Basic Information
- Device Name
- JAS MAGNESIUM REAGENT
- K Number
- K003835
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.1495
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Jas Diagnostics, Inc.
- Date Received
- December 12, 2000
- Decision Date
- March 23, 2001
- Product Code
- JGJ
- 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 |
|---|---|---|---|
| JGJ | Photometric Method, Magnesium | FDA class 1 | Clinical Chemistry |
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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 |
| K012332 | JAS CARBON DIOXIDE LIQUID REAGENT | Sep 6, 2001 | Substantially Equivalent |