510(k) K022017
- Device
- RHIGENE MESACUP-2 TEST RNP, MODEL M7741
- Applicant
- Rhigene, Inc.
- 510(k) number
- K022017
- Product code
- LKO
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2002-08-14
- Date received
- 2002-06-20
- Regulation
- 866.5100
- Classification name
- Anti-Rnp Antibody, Antigen And Control
- Medical specialty
- Immunology
- Review panel
- Immunology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Statement
- Third party reviewed
- N
Applicant Contact#
- Contact
- YUSUKE KOBE
- Address
- 455 State St., Suite 104 Des Plaines IL US 60068 60068
FDA Registration Numbers#
- 8043792
- 9680745
- 2026994
- 3007361513
- 3039353646
- 3012348571
- 3003268355
- 1421346
- 3004973408
- 3003935253
- 9610566
- 3007118747
- 2915274
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code LKO#
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| K983465 | THE APTUS (AUTOMATED) APPLICATION OF THE SM/RNP ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR THE | Zeus Scientific, Inc. | 1998-11-18 |
| K954831 | ORGENTEC ANTI-RNP/SM PIN IMMUNO ASSAY | Orgentec | 1996-05-08 |
| K954897 | HYTEC AUTOIMMUNE KITS (RNP) | Hycor Biomedical, Inc. | 1996-03-22 |
| K940588 | ENZYME IMMUNOASSAY ANTI-SM/RNP ANTIBODY TEST KIT | Helix Diagnostics, Inc. | 1994-04-20 |
| K930142 | SYNELISA U1-SNRNP (68KDA)-ANTIBODIES | Elias U.S.A., Inc. | 1993-05-11 |
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