SYNELISA SM ABS/RNP-SM ABS
FDA 510(k) clearance K930141 · decided 1993-05-11
Clearance details
- K-number
- K930141
- Device name
- SYNELISA SM ABS/RNP-SM ABS
- Applicant
- Elias U.S.A., Inc.
- Decision
- Substantially Equivalent
- Date received
- 1993-01-12
- Decision date
- 1993-05-11
- Days to decision
- 119 days
- Clearance type
- Traditional
- Product code
- LKP
- Device class
- 2
- Regulation number
- 866.5100
- Medical specialty
- Immunology
- Advisory committee
- Immunology
- Location
- Osceola, WI, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Elias U.S.A.
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 SmDP-S (K202067) | Phadia AB | 2021-07-14 |
| EliA SmDP Immunoassay (K183007) | Phadia AB | 2018-12-24 |
| EIA SMDP IMMUNOASSAY (K132631) | Phadia US, Inc. | 2014-08-29 |
| QUANTA FLASH SM, QUANTA FLASH RNP, QUANTA FLASH SM CALIBRATORS, QUANTA FLASH RNP CALIBRATORS, QUANTA FLASH SM CONTROLS, (K123593) | Inova Diagnostics, Inc. | 2013-04-17 |
| THERATEST EL-ANA PROFILES (K051066) | Theratest Laboratories, Inc. | 2005-10-07 |
| VARELISA SM ANTIBODIES, MODEL 18296 (K042629) | Sweden Diagnostics (Germany) GmbH | 2004-12-08 |
| LIQUICHEK ANTI-SM CONTROL, POSITIVE, CATALOG #115 (K024219) | Bio-Rad | 2003-01-15 |
| FRED HUTCHINSON CANCER RESEARCH CENTER ENZYME ANTI-SR PROTEIN ANTIBODY TEST (K013263) | Fred Hutchinson Cancer Research Center | 2002-07-29 |
| RHIGENE MESACUP2 TEST- SM (K000755) | Rhigene, Inc. | 2000-05-09 |
| VARELISA SM ANTIBODIES (K000312) | Pharmacia & Upjohn Co. | 2000-03-17 |
| AUTOSTAT II ANTI-SM ELISA (K990625) | Cogent Diagnotics , Ltd. | 1999-04-28 |
| LIQUICHEK ANTI-SM CONTROL, EIA, MODEL 208 (K984479) | Bio-Rad | 1998-12-22 |
Recalls involving this device
No recalls on record reference this clearance.