510(k) K071210
- Device
- MODIFICATION TO FIDIS CONNECTIVE 10*, MODEL MX006
- Applicant
- BIOMEDICAL DIAGNOSTICS (BMD) SA
- 510(k) number
- K071210
- Product code
- LKO
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2007-12-19
- Date received
- 2007-05-01
- 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
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- COURIVAUD CHRISTELLE
- Address
- Actipole 25 4-6 Bld De Beaubourg Marne La Vallee Cedex 2 FR 77435 77435
FDA Registration Numbers#
- 8043792
- 9680745
- 2026994
- 3007361513
- 3039353646
- 3012348571
- 3003268355
- 1421346
- 3004973408
- 3003935253
- 9610566
- 3007118747
- 2915274
Source Documents#
Other 510(k) Records For Product Code LKO #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K191085 | Maverick RNP Assay and Maverick Diagnostic System | Genalyte, Inc. | 2019-10-25 |
| K140224 | EUROIMMUN EUROLINE ENA PROFILE 9AG (IGG) | Euroimmun US | 2014-12-09 |
| K123261 | EUROIMMUN ANTI-NRNP/SM ELISA (IGG) | Euroimmun US | 2013-06-12 |
| K083117 | ELIA RNP70 IMMUNOASSAY, ELIA SCI-70 IMMUNOASSAY AND ELIA JO-1 IMMUNOASSAY, MODELS 14-5511-01, 14-5506-01 AND 14-5507-01 | Phadia US, Inc. | 2009-05-28 |
| K022017 | RHIGENE MESACUP-2 TEST RNP, MODEL M7741 | Rhigene, Inc. | 2002-08-14 |
| K000752 | RHIGENE MESACUP2 TEST- RNP | Rhigene, Inc. | 2000-05-09 |
| K993589 | VARELISA RNP ANTIBODIES | Pharmacia & Upjohn Co. | 1999-11-26 |
| K990624 | AUTOSTAT II ANTI-SM/RNP ELISA | Cogent Diagnotics , Ltd. | 1999-04-28 |
| K984476 | LIQUICHEK ANTI-RNP CONTROL, EIA, MODEL 207 | Bio-Rad | 1998-12-22 |
| 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 |
| K911849 | IMMUNOWELL SJOGRENS SYNDROME A (RO)ANTIBODY TEST | General Biometrics, Inc. | 1991-05-07 |
Legacy Summary#
summary
FDA Review#
Decision Summary