THE APTUS (AUTOMATED) APPLICATION OF THE SM/RNP ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR THE
FDA 510(k) clearance K983465 · decided 1998-11-18
Clearance details
- K-number
- K983465
- Device name
- THE APTUS (AUTOMATED) APPLICATION OF THE SM/RNP ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR THE
- Applicant
- Zeus Scientific, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1998-10-01
- Decision date
- 1998-11-18
- Days to decision
- 48 days
- Clearance type
- Traditional
- Product code
- LKO
- Device class
- 2
- Regulation number
- 866.5100
- Medical specialty
- Immunology
- Advisory committee
- Immunology
- Location
- Raritan, NJ, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Zeus Scientific
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 |
|---|---|---|
| Maverick RNP Assay and Maverick Diagnostic System (K191085) | Genalyte, Inc. | 2019-10-25 |
| EUROIMMUN EUROLINE ENA PROFILE 9AG (IGG) (K140224) | Euroimmun US | 2014-12-09 |
| EUROIMMUN ANTI-NRNP/SM ELISA (IGG) (K123261) | Euroimmun US | 2013-06-12 |
| ELIA RNP70 IMMUNOASSAY, ELIA SCI-70 IMMUNOASSAY AND ELIA JO-1 IMMUNOASSAY, MODELS 14-5511-01, 14-5506-01 AND 14-5507-01 (K083117) | Phadia US, Inc. | 2009-05-28 |
| MODIFICATION TO FIDIS CONNECTIVE 10*, MODEL MX006 (K071210) | Biomedical Diagnostics (Bmd) SA | 2007-12-19 |
| RHIGENE MESACUP-2 TEST RNP, MODEL M7741 (K022017) | Rhigene, Inc. | 2002-08-14 |
| RHIGENE MESACUP2 TEST- RNP (K000752) | Rhigene, Inc. | 2000-05-09 |
| VARELISA RNP ANTIBODIES (K993589) | Pharmacia & Upjohn Co. | 1999-11-26 |
| AUTOSTAT II ANTI-SM/RNP ELISA (K990624) | Cogent Diagnotics , Ltd. | 1999-04-28 |
| LIQUICHEK ANTI-RNP CONTROL, EIA, MODEL 207 (K984476) | Bio-Rad | 1998-12-22 |
| ORGENTEC ANTI-RNP/SM PIN IMMUNO ASSAY (K954831) | Orgentec | 1996-05-08 |
| HYTEC AUTOIMMUNE KITS (RNP) (K954897) | Hycor Biomedical, Inc. | 1996-03-22 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| ZEUS ELISA PARVOVIRUS B19 IGM TEST SYSTEM (P150042) | Zeus Scientific, Inc. | 2017-09-19 |
| ZEUS ELISA PARVOVIRUS B19 IGG TEST SYSTEM (P150045) | Zeus Scientific, Inc. | 2017-09-19 |
| FLUORO-CEP (R) PROGESTERONE (P900025/S001) | Zeus Scientific, Inc. | 1992-04-21 |
| FLUORO-CEP (R) PROGESTERONE (P900025/S002) | Zeus Scientific, Inc. | 1992-04-17 |
| FLUORO-CEP (R) PROGESTERONE (P900025) | Zeus Scientific, Inc. | 1990-09-26 |