MESACUP-2 Test JO-1, Model 10756
FDA 510(k) K033528 · Rhigene, Inc.
510(k) numberK033528
Submission
- Device name
- MESACUP-2 Test JO-1, Model 10756
- Applicant
- Rhigene, Inc.
Westminster, CO, US - Received
- November 7, 2003
- Decision date
- December 22, 2003
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- LLL – Extractable Antinuclear Antibody, Antigen And Control
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.5100
- Specialty
- Immunology
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| 510(k) | Device | Decision |
|---|---|---|
| K040711 | Mesacup Test PR-3MOB · Traditional | 04/02/2004SE |
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| K040200 | MESACUP-2 Test Cenp-BLJM · Traditional | 03/04/2004SE |
| K031308 | Rhigene MESACUP-2 Anti-Mitochondria M2 Test, Model 10760DBM · Traditional | 09/26/2003SE |
| K022017 | Rhigene MESACUP-2 Test RNP, Model M7741LKO · Traditional | 08/14/2002SE |
| K022018 | Rhigene Ana Elisa Test System, Model K7560LJM · Special | 07/05/2002SE |
| K011068 | Rhigene Ndna Test System for Imagetiter, Model CL100LKTL · Traditional | 04/11/2002SE |
| K000336 | Rhigene DSG-1 & DSG-3 Elisa Test System, Model 7680 ENBO · Traditional | 06/09/2000SE |
| K000755 | Rhigene MESACUP2 Test- SMLKP · Traditional | 05/09/2000SE |
| K000752 | Rhigene MESACUP2 Test- RNPLKO · Traditional | 05/09/2000SE |
Questions and answers
When was MESACUP-2 Test JO-1, Model 10756 cleared by the FDA?
MESACUP-2 Test JO-1, Model 10756 (K033528) received a 510(k) decision of Substantially Equivalent on December 22, 2003, 45 days after the submission was received.
What is the product code of K033528?
The FDA product code is LLL – Extractable Antinuclear Antibody, Antigen And Control, a Class II (moderate risk) device regulated under 21 CFR 866.5100.