FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
COLUMNMATE (AUTOMATED COLUMN SYSTEM) 1580, 1581
K Number: K901414
·
Decision Jun 15, 1990
Classifications
1
FEI Numbers
65
Registration Numbers
65
Same Product Code
248
Applicant Total
280
Review Days
81
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
- COLUMNMATE (AUTOMATED COLUMN SYSTEM) 1580, 1581
- K Number
- K901414
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 864.7470
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Applicant
- Helena Laboratories
- Date Received
- March 26, 1990
- Decision Date
- June 15, 1990
- 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 Helena Laboratories
| K Number | Device Name | ||
|---|---|---|---|
| K131479 | V8 SP NORMAL CONTROL, ABNORMAL CONTROL | Oct 7, 2013 | Substantially Equivalent |
| K100103 | SPECIALTY ASSAYED CONTROL-2 | Dec 15, 2010 | Substantially Equivalent |
| K061991 | PLATELETWORKS ARACHIDONIC ACID, MODEL PW-ACA | Feb 23, 2007 | Substantially Equivalent |
| K061069 | SPIFE IFE-15 PENTAVALENT, MODEL 3456, SPIFE IFE-9 PENTAVALENT KIT, MODEL 3457, SPIFT IFE-6 PENTAVALENT KIT, MODEL 3458 | Jul 6, 2006 | Substantially Equivalent |
| K061014 | ACTALYKE QC KIT, MODELS AQC-HP AND AQC-LP | May 10, 2006 | Substantially Equivalent |
| K050053 | HEMORAM/AGGRAM ANALYZER | Jul 11, 2005 | Substantially Equivalent |
| K024162 | SPIFE 3000 TITAN GEL IGG IEF KIT, MODEL 3389 | Feb 19, 2003 | Substantially Equivalent |
| K023761 | PLATELETWORKS, MODELS PW-A, PW-C | Feb 14, 2003 | Substantially Equivalent |
| K022757 | SPIFE CK KIT, MODEL 3332, 3333 | Oct 11, 2002 | Substantially Equivalent |
| K022455 | SPIFE LD-12 KIT, MODEL 3338 | Oct 1, 2002 | Substantially Equivalent |