FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ATAC HEMOGLOBIN A1C REAGENT KIT
K Number: K031042
·
Decision Nov 3, 2003
Classifications
1
FEI Numbers
65
Registration Numbers
65
Same Product Code
248
Applicant Total
36
Review Days
216
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
- ATAC HEMOGLOBIN A1C REAGENT KIT
- K Number
- K031042
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 864.7470
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Clinical Data, Inc.
- Date Received
- April 1, 2003
- Decision Date
- November 3, 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 Clinical Data, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K071706 | ENVOY 500 HDL; CHOLESTEROL REAGENT KIT (MODEL# 55301), CALIBRATOR KIT (MODEL# 55118) | Dec 20, 2007 | Substantially Equivalent |
| K052591 | NANOPIA WIDE RANGE C-REACTIVE PROTEIN (CRP) REAGENT KIT | Feb 9, 2006 | Substantially Equivalent |
| K033983 | VITALAB IRON REAGENT | May 21, 2004 | Substantially Equivalent |
| K040631 | VITALAB DIRECT BILIRUBIN REAGENT | Mar 18, 2004 | Substantially Equivalent |
| K040534 | VITALAB AMYLASE REAGENT | Mar 11, 2004 | Substantially Equivalent |
| K034000 | VITALAB TRIGLYCERIDES REAGENT AND VITALAB CALIBRATOR | Mar 10, 2004 | Substantially Equivalent |
| K040508 | VITALAB MAGNESIUM REAGENT | Mar 8, 2004 | Substantially Equivalent |
| K040467 | VITALAB URIC ACID REAGENT | Mar 8, 2004 | Substantially Equivalent |
| K031044 | ATAC PAK URIC ACID REAGENT AND ATAC CALIBRATOR | Jul 15, 2003 | Substantially Equivalent |
| K863904 | DISPOSABLE ECG MONITORING ELECTRODE | Jan 6, 1987 | Substantially Equivalent |