FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MESACUP TEST PR-3
K Number: K040711
·
Decision Apr 2, 2004
Classifications
1
FEI Numbers
26
Registration Numbers
26
Same Product Code
73
Applicant Total
15
Review Days
15
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Basic Information
- Device Name
- MESACUP TEST PR-3
- K Number
- K040711
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.5660
- Medical Specialty
- Immunology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Rhigene, Inc.
- Date Received
- March 18, 2004
- Decision Date
- April 2, 2004
- Product Code
- MOB
- Advisory Committee
- Immunology
- Review Advisory Committee
- IM
- 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 |
|---|---|---|---|
| MOB | Test System, Antineutrophil Cytoplasmic Antibodies (Anca) | FDA class 2 | Immunology |
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Other Clearances by Rhigene, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K040586 | MESACUP TEST MPO, MODEL 11053 | Mar 22, 2004 | Substantially Equivalent |
| K040200 | MESACUP-2 TEST CENP-B | Mar 4, 2004 | Substantially Equivalent |
| K033528 | MESACUP-2 TEST JO-1, MODEL 10756 | Dec 22, 2003 | Substantially Equivalent |
| K031308 | RHIGENE MESACUP-2 ANTI-MITOCHONDRIA M2 TEST, MODEL 10760 | Sep 26, 2003 | Substantially Equivalent |
| K022017 | RHIGENE MESACUP-2 TEST RNP, MODEL M7741 | Aug 14, 2002 | Substantially Equivalent |
| K022018 | RHIGENE ANA ELISA TEST SYSTEM, MODEL K7560 | Jul 5, 2002 | Substantially Equivalent |
| K011068 | RHIGENE NDNA TEST SYSTEM FOR IMAGETITER, MODEL CL100L | Apr 11, 2002 | Substantially Equivalent |
| K000336 | RHIGENE DSG-1 & DSG-3 ELISA TEST SYSTEM, MODEL 7680 E | Jun 9, 2000 | Substantially Equivalent |
| K000751 | RHIGENE MESACUP2 TEST- SSB | May 9, 2000 | Substantially Equivalent |
| K000755 | RHIGENE MESACUP2 TEST- SM | May 9, 2000 | Substantially Equivalent |