FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
POLY-CHEM 90 ISE MODULE
K Number: K112408
·
Decision Nov 4, 2011
Classifications
1
FEI Numbers
82
Registration Numbers
82
Same Product Code
88
Applicant Total
19
Review Days
74
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Basic Information
- Device Name
- POLY-CHEM 90 ISE MODULE
- K Number
- K112408
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1600
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Polymedco, Inc.
- Date Received
- August 22, 2011
- Decision Date
- November 4, 2011
- Product Code
- CEM
- 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 |
|---|---|---|---|
| CEM | Electrode, Ion Specific, Potassium | FDA class 2 | Clinical Chemistry |
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Other Clearances by Polymedco, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K110818 | POLY-CHEM 90 ALBUMIN, BUN, CALCIUM, CARBON DIOXIDE, CREATININE, AND TOTAL PROTEIN TESTS | Sep 8, 2011 | Substantially Equivalent |
| K111143 | POLY-CHEM 90 TOTAL BILIRUBIN | Sep 1, 2011 | Substantially Equivalent |
| K100550 | POLY-CHEM 90 DIRECT HDL CHOLESTEROL, POLY-CHEM 90 DIRECT LDL CHOLESTEROL, POLY-CHEM 90 CHOLESTEROL, POLY-CHEM 90 TRIGLYC | Sep 28, 2010 | Substantially Equivalent |
| K090703 | POLY-CHEM 90 GLUCOSE | Oct 20, 2009 | Substantially Equivalent |
| K061944 | POLY-CHEM CREATININE | Nov 3, 2006 | Substantially Equivalent |
| K053553 | NYCOCARD U-ALBUMIN AND U-ALBUMIN CONTROL | Mar 9, 2006 | Substantially Equivalent |
| K041408 | POLYMEDCO OC AUTO MICRO 80 FOB TEST | Oct 21, 2004 | Substantially Equivalent |
| K041297 | POLYMEDCO OC LIGHT FOBT TEST | Aug 12, 2004 | Substantially Equivalent |
| K033706 | POLYMEDCO HOMOCYSTEINE TEST FOR THE POLY-CHEM AND HITACHI CHEMISTRY SYSTEMS | Feb 4, 2004 | Substantially Equivalent |
| K023654 | GLYCA-DIRECT FRUCTOSAMINE | May 2, 2003 | Substantially Equivalent |