FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
GLYCA-DIRECT FRUCTOSAMINE
K Number: K023654
·
Decision May 2, 2003
Classifications
1
FEI Numbers
65
Registration Numbers
65
Same Product Code
248
Applicant Total
19
Review Days
184
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
- GLYCA-DIRECT FRUCTOSAMINE
- K Number
- K023654
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 864.7470
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Polymedco, Inc.
- Date Received
- October 30, 2002
- Decision Date
- May 2, 2003
- Product Code
- LCP
- Advisory Committee
- Hematology
- 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 |
|---|---|---|---|
| LCP | Assay, Glycosylated Hemoglobin | FDA class 2 | Hematology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (LCP), ordered by most recent decision date.
Nova Allegro HbA1c Assay, Nova Allegro Analyzer
FDA 510(k)
FDA Class 2
·Hematology
Q-Pad Test System
FDA 510(k)
FDA Class 2
·Hematology
Afinion HbA1c, Afinion 2 and Alere Afinion AS100 Analyzer
FDA 510(k)
FDA Class 2
·Hematology
Aina HbA1c Monitoring System 2
FDA 510(k)
FDA Class 2
·Hematology
PixoTest POCT System - PixoTest POCT Analyzer and PixoTest A1c Test Kit
FDA 510(k)
FDA Class 2
·Hematology
OneDraw A1C Test System
FDA 510(k)
FDA Class 2
·Hematology
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 |
| 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 |