510(k) K082759
- Device
- ELIA CENP IMMUNOASSAY, ELIA U1RNP IMMUNOASSAY, ELIA SM IMMUNOASSAY, ELIA RO IMMUNOASSAY
- Applicant
- PHADIA US INC.
- 510(k) number
- K082759
- Product code
- LKJ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2009-04-10
- Date received
- 2008-09-22
- Regulation
- 866.5100
- Classification name
- Antinuclear Antibody, Antigen, Control
- Medical specialty
- Immunology
- Review panel
- Immunology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- MARTIN R MANN
- Address
- 4169 Commercial Ave. Portage MI US 49002 49002
FDA Registration Numbers#
- 9680745
- 3015376545
- 3003825930
- 3032705
- 2915274
- 3003935253
- 3039353646
- 2016706
- 2026994
- 8043792
- 2918768
- 2242436
- 1181055
- 3004973408
- 1318354
- 3007208259
- 3010127294
- 9610566
Source Documents#
Other 510(k) Records For Product Code LKJ #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K210902 | EliA Ro52, EliA Ro60 | Phadia AB | 2022-07-27 |
| K113610 | ANA-SCREEN WITH MDSS | Bio-Rad Laboratories | 2012-07-09 |
| K081104 | AESKULISA ANA HEP-2, REF 30-7115US | Aesku Diagnostics | 2008-05-02 |
| K041658 | BIOPLEX 200 ANA SCREEN ON THE BIOPLEX 2200 MULTI-ANALYTE DETECTION SYSTEM, MODEL BIOPLEX 2200 | Bio-Rad Laboratories, Inc. | 2004-12-20 |
| K042416 | ATHENA MULTI-LYTE ANA-II TEST SYSTEM | Zeus Scientific, Inc. | 2004-10-08 |
| K034013 | REAADS DSDNA QUANTITATIVE TEST KIT, MODEL 022-001 | Corgenix, Inc. | 2004-01-08 |
| K030775 | AUTO I.D. JO-1, SCL-70 & PCNA POSITIVE CONTROL SERUM | Immuno Concepts, N.A. , Ltd. | 2003-05-12 |
| K024218 | LIQUICHEK ANTI-SS-A CONTROL, POSITIVE, CATALOG #114 | Bio-Rad | 2003-01-17 |
| K024232 | LIQUICHEK ANTI-SS-B CONTROL, POSITIVE, CATALOG #113 | Bio-Rad | 2003-01-17 |
| K024223 | LIQUICHEK ANTI-RNP CONTROL, POSITIVE, CATALOG #116 | Bio-Rad | 2003-01-13 |
| K024226 | LIQUICHEK ANTI-SCL-70 CONTROL, POSITIVE, CATALOG #116 | Bio-Rad | 2003-01-10 |
| K021257 | ANA LINE BLOT, CATALOG NUMBER: KALABI (20 TESTS) | Diagnostic Products Corp. | 2002-06-03 |
| K021103 | MODIFICATION TO ZEUS SCIENTIFIC'S ATHENA MULTI-LYTE ANA TEST SYSTEM | Zeus Scientific, Inc. | 2002-04-24 |
| K011244 | ZEUS SCIENTIFIC, INC. ATHENA MULTI-LYTE ANA TEST SYSTEM | Zeus Scientific, Inc. | 2001-12-10 |
| K993294 | DIAMEDIX IS-ANA ELISA SCREEN TEST SYSTEM | Diamedix Corp. | 1999-10-25 |
Legacy Summary#
summary
FDA Review#
Decision Summary