Rhigene MESACUP-2 Anti-Mitochondria M2 Test, Model 10760
FDA 510(k) K031308 · Rhigene, Inc.
510(k) numberK031308
Submission
- Device name
- Rhigene MESACUP-2 Anti-Mitochondria M2 Test, Model 10760
- Applicant
- Rhigene, Inc.
Westminster, CO, US - Received
- April 24, 2003
- Decision date
- September 26, 2003
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DBM – Antimitochondrial Antibody, Indirect Immunofluorescent, Antigen, Control
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.5090
- Specialty
- Immunology
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| K052262 | Quanta Lite M2 Ep (MIT3) ElisaDBM · Traditional | Inova Diagnostics, Inc. | 10/27/2005SE |
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| 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 Rhigene MESACUP-2 Anti-Mitochondria M2 Test, Model 10760 cleared by the FDA?
Rhigene MESACUP-2 Anti-Mitochondria M2 Test, Model 10760 (K031308) received a 510(k) decision of Substantially Equivalent on September 26, 2003, 155 days after the submission was received.
What is the product code of K031308?
The FDA product code is DBM – Antimitochondrial Antibody, Indirect Immunofluorescent, Antigen, Control, a Class II (moderate risk) device regulated under 21 CFR 866.5090.