FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
POLY-CHEM 90 DIRECT HDL CHOLESTEROL, POLY-CHEM 90 DIRECT LDL CHOLESTEROL, POLY-CHEM 90 CHOLESTEROL, POLY-CHEM 90 TRIGLYC
K Number: K100550
·
Decision Sep 28, 2010
Classifications
1
FEI Numbers
45
Registration Numbers
45
Same Product Code
79
Applicant Total
19
Review Days
214
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Basic Information
- Device Name
- POLY-CHEM 90 DIRECT HDL CHOLESTEROL, POLY-CHEM 90 DIRECT LDL CHOLESTEROL, POLY-CHEM 90 CHOLESTEROL, POLY-CHEM 90 TRIGLYC
- K Number
- K100550
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.1475
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Polymedco, Inc.
- Date Received
- February 26, 2010
- Decision Date
- September 28, 2010
- Product Code
- LBS
- 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 |
|---|---|---|---|
| LBS | Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl | FDA class 1 | Clinical Chemistry |
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Other Clearances by Polymedco, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K112408 | POLY-CHEM 90 ISE MODULE | Nov 4, 2011 | Substantially Equivalent |
| 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 |
| 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 |