IMMUSTRIP(TM) SM ELISA TEST SYSTEM
FDA 510(k) clearance K873741 · decided 1987-11-04
Clearance details
- K-number
- K873741
- Device name
- IMMUSTRIP(TM) SM ELISA TEST SYSTEM
- Applicant
- Immunomedics, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1987-09-16
- Decision date
- 1987-11-04
- Days to decision
- 49 days
- Clearance type
- Traditional
- Product code
- LKP
- Device class
- 2
- Regulation number
- 866.5100
- Medical specialty
- Immunology
- Advisory committee
- Immunology
- Location
- Newark, NJ, US
- Third-party review
- No
- Expedited review
- No
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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.