FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MULTIGENT HEMOGLOBIN A1C (REAGENTS), HB A1C CALIBRATORS AND HB A1C CONTROLS
K Number: K033674
·
Decision Feb 9, 2004
Classifications
1
FEI Numbers
65
Registration Numbers
65
Same Product Code
248
Applicant Total
28
Review Days
77
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
- MULTIGENT HEMOGLOBIN A1C (REAGENTS), HB A1C CALIBRATORS AND HB A1C CONTROLS
- K Number
- K033674
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 864.7470
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Seradyn, Inc.
- Date Received
- November 24, 2003
- Decision Date
- February 9, 2004
- 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 Seradyn, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K070645 | SERADYN QMS TOPIRAMATE | May 17, 2007 | Substantially Equivalent |
| K062966 | QMS LAMOTRIGINE ASSAY (REAGENTS), CALIBRATORS & CONTROLS | Jan 12, 2007 | Substantially Equivalent |
| K062204 | ARCHITECT CORTISOL ASSAY | Sep 22, 2006 | Substantially Equivalent |
| K060998 | QMS TOBRAMYCIN | Jul 21, 2006 | Substantially Equivalent |
| K060709 | MULTIGENT GENTAMICIN | Jun 15, 2006 | Substantially Equivalent |
| K052826 | QMS QUINIDINE. QMS QUINIDINE CALIBRATORS | Dec 23, 2005 | Substantially Equivalent |
| K051211 | QMS ZONISAMIDE REAGENTS, CALIBRATORS AND CONTROLS | Nov 18, 2005 | Substantially Equivalent |
| K052815 | QMS AMIKACIN REAGENTS | Nov 1, 2005 | Substantially Equivalent |
| K050419 | QMS VANCOMYCIN | Apr 1, 2005 | Substantially Equivalent |
| K042307 | ARCHITECT T-UPTAKE CALIBRATORS (A-F) AND CONTROLS (LOW, HIGH) | Nov 3, 2004 | Substantially Equivalent |