FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
GEN-PROBE APTIMA COMBO 2 ASSAY
K Number: K043224
·
Decision Aug 9, 2005
Classifications
1
FEI Numbers
28
Registration Numbers
28
Same Product Code
44
Applicant Total
62
Review Days
260
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Basic Information
- Device Name
- GEN-PROBE APTIMA COMBO 2 ASSAY
- K Number
- K043224
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.3390
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Gen-Probe, Inc.
- Date Received
- November 22, 2004
- Decision Date
- August 9, 2005
- Product Code
- LSL
- Advisory Committee
- Microbiology
- Review Advisory Committee
- MI
- 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 |
|---|---|---|---|
| LSL | Dna-Reagents, Neisseria | FDA class 2 | Microbiology |
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Other Clearances by Gen-Probe, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K122062 | APTIMA TRICHOMONAS VAGINALIS ASSAY - PANTHER | Jan 9, 2013 | Substantially Equivalent |
| K111409 | APTIMA COMBO 2 ASSAY | May 3, 2012 | Substantially Equivalent |
| K063664 | GEN-PROBE APTIMA ASSAY FOR NEISSERIA GONORRHOEAE MODEL#1091 | Jan 25, 2007 | Substantially Equivalent |
| K063451 | GEN-PROBE APTIMA ASSAY FOR CHLAMYDIA TRACHOMATIS, MODEL 1199 | Jan 22, 2007 | Substantially Equivalent |
| K062440 | GEN-PROBE APTIMA ASSAY FOR NEISSERIA GONORRHOEAE, MODEL 1091 | Nov 7, 2006 | Substantially Equivalent |
| K061413 | APTIMA CT ASSAY ON THE TIGRIS DTS SYSTEM | Oct 13, 2006 | Substantially Equivalent |
| K061509 | TIGRIS DTS GEN-PROBE APTIMA ASSAY FOR NEISSERIA GONORRHOEAE, MODEL 1196 | Oct 4, 2006 | Substantially Equivalent |
| K060652 | TIGRIS DTS GEN-PROBE APTIMA COMBO 2 ASSAY | Aug 17, 2006 | Substantially Equivalent |
| K053446 | GEN-PROBE APTIMA ASSAY FOR CHLAMYDIA TRACHOMATIS, MODEL 1088 | Jul 25, 2006 | Substantially Equivalent |
| K043144 | GEN-PROBE APTIMA ASSAY FOR NEISSERIA GONORRHOEAE | Mar 14, 2005 | Substantially Equivalent |