FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MESACUP-2 TEST JO-1, MODEL 10756
K Number: K033528
·
Decision Dec 22, 2003
Classifications
1
FEI Numbers
25
Registration Numbers
25
Same Product Code
179
Applicant Total
15
Review Days
45
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
- MESACUP-2 TEST JO-1, MODEL 10756
- K Number
- K033528
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.5100
- Medical Specialty
- Immunology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Rhigene, Inc.
- Date Received
- November 7, 2003
- Decision Date
- December 22, 2003
- Product Code
- LLL
- 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 |
|---|---|---|---|
| LLL | Extractable Antinuclear Antibody, Antigen And Control | FDA class 2 | Immunology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (LLL), ordered by most recent decision date.
Alegria Flash CTD Screen
FDA 510(k)
FDA Class 2
·Immunology
Alegria Flash ENA Screen
FDA 510(k)
FDA Class 2
·Immunology
Aptiva CTD Essential Reagent
FDA 510(k)
FDA Class 2
·Immunology
EliA SymphonyS Immunoassay
FDA 510(k)
FDA Class 2
·Immunology
QUANTA Flash HMGCR Reagents
FDA 510(k)
FDA Class 2
·Immunology
QUANTA Flash Scl-70, QUANTA Flash Scl-70 Calibrators, QUANTA Flash Scl-70 Controls
FDA 510(k)
FDA Class 2
·Immunology
Other Clearances by Rhigene, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K040711 | MESACUP TEST PR-3 | Apr 2, 2004 | Substantially Equivalent |
| K040586 | MESACUP TEST MPO, MODEL 11053 | Mar 22, 2004 | Substantially Equivalent |
| K040200 | MESACUP-2 TEST CENP-B | Mar 4, 2004 | 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 |