FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PRIMUS RAPID GEL 100 GLYCATED HEMOGLOBIN ASSAY
K Number: K942009
·
Decision Sep 14, 1994
Classifications
1
FEI Numbers
65
Registration Numbers
65
Same Product Code
248
Applicant Total
11
Review Days
142
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
- PRIMUS RAPID GEL 100 GLYCATED HEMOGLOBIN ASSAY
- K Number
- K942009
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 864.7470
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Primus Corp.
- Date Received
- April 25, 1994
- Decision Date
- September 14, 1994
- Product Code
- LCP
- Advisory Committee
- Hematology
- Review Advisory Committee
- HE
- 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 Primus Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K062658 | PRIMUS A1CARE ASSAY | Nov 26, 2007 | Substantially Equivalent |
| K013787 | NYCOCARD CRP | May 14, 2002 | Substantially Equivalent |
| K014084 | NYCOCARD CRP CONTROL | Jan 7, 2002 | Substantially Equivalent |
| K994045 | PRIMUS LIQUID CALIBRATOR FOR GHB/A1C LEVEL 1 AND LEVEL 2 | Dec 21, 1999 | Substantially Equivalent |
| K992921 | PRIMUS LIQUID CONTROL FOR GHB/ALC LEVEL I AND LEVEL II | Nov 12, 1999 | Substantially Equivalent |
| K955283 | PRIMUS VARIANT SYSTEM PVS99 | Mar 1, 1996 | Substantially Equivalent |
| K940008 | GLYCATED PROTEIN CALIBRATORS | May 9, 1994 | Substantially Equivalent |
| K940142 | GLYCATED PROTEIN CONTROLS | Apr 26, 1994 | Substantially Equivalent |
| K936204 | GLYCATED HEMOGLOBIN CALIBRATORS | Mar 22, 1994 | Substantially Equivalent |
| K940143 | GLYCATED HEMOGLOBIN CONTROLS | Mar 15, 1994 | Substantially Equivalent |