510(k) K873741
- Device
- IMMUSTRIP(TM) SM ELISA TEST SYSTEM
- Applicant
- IMMUNOMEDICS, INC.
- 510(k) number
- K873741
- Product code
- LKP
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1987-11-04
- Date received
- 1987-09-16
- Regulation
- 866.5100
- Classification name
- Anti-sm Antibody, Antigen And Control
- Medical specialty
- Immunology
- Review panel
- Immunology
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- LINDA L NARDONE,PHD
- Address
- 5 Bruce St., Bldg. #5 Newark NJ US 07103 07103
FDA Registration Numbers#
- 9680745
- 3015376545
- 1421346
- 2915274
- 3012348571
- 3039353646
- 2016706
- 3003935253
- 2026994
- 8043792
- 3007118747
- 3003268355
- 3004973408
- 3007361513
- 3010127294
- 2432235
- 9610566
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code LKP #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K202067 | EliA SmDP-S | Phadia AB | 2021-07-14 |
| K183007 | EliA SmDP Immunoassay | Phadia AB | 2018-12-24 |
| K132631 | EIA SMDP IMMUNOASSAY | Phadia US, Inc. | 2014-08-29 |
| K123593 | QUANTA FLASH SM, QUANTA FLASH RNP, QUANTA FLASH SM CALIBRATORS, QUANTA FLASH RNP CALIBRATORS, QUANTA FLASH SM CONTROLS, | Inova Diagnostics, Inc. | 2013-04-17 |
| K051066 | THERATEST EL-ANA PROFILES | Theratest Laboratories, Inc. | 2005-10-07 |
| K042629 | VARELISA SM ANTIBODIES, MODEL 18296 | Sweden Diagnostics (Germany) GmbH | 2004-12-08 |
| K024219 | LIQUICHEK ANTI-SM CONTROL, POSITIVE, CATALOG #115 | Bio-Rad | 2003-01-15 |
| K013263 | FRED HUTCHINSON CANCER RESEARCH CENTER ENZYME ANTI-SR PROTEIN ANTIBODY TEST | Fred Hutchinson Cancer Research Center | 2002-07-29 |
| K000755 | RHIGENE MESACUP2 TEST- SM | Rhigene, Inc. | 2000-05-09 |
| K000312 | VARELISA SM ANTIBODIES | Pharmacia & Upjohn Co. | 2000-03-17 |
| K990625 | AUTOSTAT II ANTI-SM ELISA | Cogent Diagnotics , Ltd. | 1999-04-28 |
| K984479 | LIQUICHEK ANTI-SM CONTROL, EIA, MODEL 208 | Bio-Rad | 1998-12-22 |
| K983420 | THE APTUS(AUTOMATED)APPLICATION OF THE SM ELISA TEST SYSTEM.AN ENZYME LINK IMMUNOSORBENT ASSAY(ELISA)FOR THE DETECTIOO | Zeus Scientific, Inc. | 1998-11-18 |
| K980540 | SERAQUEST ANTI-SM | Quest Intl., Inc. | 1998-06-15 |
| K980811 | SERAQUEST ANTI-SM/RNP | Quest Intl., Inc. | 1998-05-12 |
Legacy Summary#
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FDA Review#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases