Rhigene MESACUP2 Test- SM
FDA 510(k) K000755 · Rhigene, Inc.
510(k) numberK000755
Submission
- Device name
- Rhigene MESACUP2 Test- SM
- Applicant
- Rhigene, Inc.
Des Plaines, IL, US - Received
- March 8, 2000
- Decision date
- May 9, 2000
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- LKP – Anti-Sm Antibody, Antigen And Control
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.5100
- Specialty
- Immunology
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| K132631 | Eia SMDP ImmunoassayLKP · Traditional | Phadia US, Inc. | 08/29/2014SE |
| K123593 | Quanta Flash SM, Quanta Flash RNP, Quanta Flash SM Calibrators, Quanta Flash RNP…LKP · Traditional | Inova Diagnostics, Inc. | 04/17/2013SE |
| K051066 | Theratest El-Ana ProfilesLKP · Traditional | Theratest Laboratories, Inc. | 10/07/2005SE |
| K042629 | Varelisa SM Antibodies, Model 18296LKP · Traditional | Sweden Diagnostics (Germany) GmbH | 12/08/2004SE |
| K024219 | Liquichek Anti-Sm Control, Positive, Catalog #115LKP · Traditional | Bio-Rad | 01/15/2003SE |
| K013263 | Fred Hutchinson Cancer Research Center Enzyme Anti-Sr Protein Antibody TestLKP · Traditional | Fred Hutchinson Cancer Research Center | 07/29/2002SE |
| K000312 | Varelisa SM AntibodiesLKP · Traditional | Pharmacia & Upjohn Co. | 03/17/2000SE |
| K990625 | Autostat II Anti-Sm ElisaLKP · Traditional | Cogent Diagnotics , Ltd. | 04/28/1999SE |
More from Cogent Diagnotics , Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K040711 | Mesacup Test PR-3MOB · Traditional | 04/02/2004SE |
| K040586 | Mesacup Test Mpo, Model 11053MOB · Traditional | 03/22/2004SE |
| K040200 | MESACUP-2 Test Cenp-BLJM · Traditional | 03/04/2004SE |
| K033528 | MESACUP-2 Test JO-1, Model 10756LLL · Traditional | 12/22/2003SE |
| 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 |
| K000752 | Rhigene MESACUP2 Test- RNPLKO · Traditional | 05/09/2000SE |
Questions and answers
When was Rhigene MESACUP2 Test- SM cleared by the FDA?
Rhigene MESACUP2 Test- SM (K000755) received a 510(k) decision of Substantially Equivalent on May 9, 2000, 62 days after the submission was received.
What is the product code of K000755?
The FDA product code is LKP – Anti-Sm Antibody, Antigen And Control, a Class II (moderate risk) device regulated under 21 CFR 866.5100.