BIOPLEX 200 ANA SCREEN ON THE BIOPLEX 2200 MULTI-ANALYTE DETECTION SYSTEM, MODEL BIOPLEX 2200
FDA 510(k) clearance K041658 · decided 2004-12-20
Clearance details
- K-number
- K041658
- Device name
- BIOPLEX 200 ANA SCREEN ON THE BIOPLEX 2200 MULTI-ANALYTE DETECTION SYSTEM, MODEL BIOPLEX 2200
- Applicant
- Bio-Rad Laboratories, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2004-06-18
- Decision date
- 2004-12-20
- Days to decision
- 185 days
- Clearance type
- Traditional
- Product code
- LKJ
- Device class
- 2
- Regulation number
- 866.5100
- Medical specialty
- Immunology
- Advisory committee
- Immunology
- Location
- Redmond, WA, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Bio-Rad Laboratories
The Builder collects up to 8 candidate devices side by side with yours, then exports the substantial-equivalence comparison scaffold. How it works
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| EliA Ro52, EliA Ro60 (K210902) | Phadia AB | 2022-07-27 |
| ANA-SCREEN WITH MDSS (K113610) | Bio-Rad Laboratories | 2012-07-09 |
| ELIA CENP IMMUNOASSAY, ELIA U1RNP IMMUNOASSAY, ELIA SM IMMUNOASSAY, ELIA RO IMMUNOASSAY (K082759) | Phadia US, Inc. | 2009-04-10 |
| AESKULISA ANA HEP-2, REF 30-7115US (K081104) | Aesku Diagnostics | 2008-05-02 |
| ATHENA MULTI-LYTE ANA-II TEST SYSTEM (K042416) | Zeus Scientific, Inc. | 2004-10-08 |
| REAADS DSDNA QUANTITATIVE TEST KIT, MODEL 022-001 (K034013) | Corgenix, Inc. | 2004-01-08 |
| AUTO I.D. JO-1, SCL-70 & PCNA POSITIVE CONTROL SERUM (K030775) | Immuno Concepts, N.A. , Ltd. | 2003-05-12 |
| LIQUICHEK ANTI-SS-A CONTROL, POSITIVE, CATALOG #114 (K024218) | Bio-Rad | 2003-01-17 |
| LIQUICHEK ANTI-SS-B CONTROL, POSITIVE, CATALOG #113 (K024232) | Bio-Rad | 2003-01-17 |
| LIQUICHEK ANTI-RNP CONTROL, POSITIVE, CATALOG #116 (K024223) | Bio-Rad | 2003-01-13 |
| LIQUICHEK ANTI-SCL-70 CONTROL, POSITIVE, CATALOG #116 (K024226) | Bio-Rad | 2003-01-10 |
| ANA LINE BLOT, CATALOG NUMBER: KALABI (20 TESTS) (K021257) | Diagnostic Products Corp. | 2002-06-03 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| MONOLISA ANTI-HBC IGM EIA (P060034/S008) | Bio-Rad Laboratories, Inc. | 2014-03-19 |
| BIO-RAD MONOLISA ANTI-HBC IGM EIA (P060034/S007) | Bio-Rad Laboratories, Inc. | 2013-12-12 |
| BIO-RAD MONOLISA ANTI-HBC EIA (P060031/S007) | Bio-Rad Laboratories, Inc. | 2013-12-12 |
| BIO-RAD MONOLISA ANTI-HBC EIA (P060031/S006) | Bio-Rad Laboratories, Inc. | 2012-11-13 |
| BIO-RAD MONOLISA ANTI-HBC IGM EIA (P060034/S006) | Bio-Rad Laboratories, Inc. | 2012-11-13 |
| BIO-RAD MONOLISA ANTI-HBC EIA (P060031/S005) | Bio-Rad Laboratories, Inc. | 2011-04-28 |
| BIO-RAD MONOLISA ANTI-HBC EIA (P060031/S003) | Bio-Rad Laboratories, Inc. | 2010-12-30 |
| MONOLISA ANTI-HBC IGM EIA (P060034/S005) | Bio-Rad Laboratories, Inc. | 2010-11-23 |