FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ACTALYKE QC KIT, MODELS AQC-HP AND AQC-LP
K Number: K061014
·
Decision May 10, 2006
Classifications
1
FEI Numbers
39
Registration Numbers
39
Same Product Code
180
Applicant Total
280
Review Days
27
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
- ACTALYKE QC KIT, MODELS AQC-HP AND AQC-LP
- K Number
- K061014
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 864.5425
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Helena Laboratories
- Date Received
- April 13, 2006
- Decision Date
- May 10, 2006
- Product Code
- JPA
- 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 |
|---|---|---|---|
| JPA | System, Multipurpose For In Vitro Coagulation Studies | FDA class 2 | Hematology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (JPA), ordered by most recent decision date.
STA Satellite Max®
FDA 510(k)
FDA Class 2
·Hematology
Automated Blood Coagulation Analyzer CN-Series (CN-6000)
FDA 510(k)
FDA Class 2
·Hematology
TEG 6s Hemostasis System Citrated: K, KH, RT, FF Assay Cartridge
FDA 510(k)
FDA Class 2
·Hematology
TEG 6s Hemostasis System Citrated: K, KH, RT, FF Assay Cartridge
FDA 510(k)
FDA Class 2
·Hematology
Citrated: K, KH, RTH, FFH
FDA 510(k)
FDA Class 2
·Hematology
ACL TOP 970 CL
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 |
| 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 |
| K022333 | SPIFE LIPPOROTEIN-12, MODEL 3344 | Aug 15, 2002 | Substantially Equivalent |