Varelisa Recombi Ana Screen Eia, Models 128 48/ 128 96
FDA 510(k) K993108 · Pharmacia & Upjohn Co.
510(k) numberK993108
Submission
- Device name
- Varelisa Recombi Ana Screen Eia, Models 128 48/ 128 96
- Applicant
- Pharmacia & Upjohn Co.
Westervillle, OH, US - Received
- September 17, 1999
- Decision date
- November 12, 1999
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- LJM – Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.5100
- Specialty
- Immunology
Other 510(k)s with product code LJM
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K182353 | EliA CENP Immunoassay, EliA U1RNP Immunoassay, EliA RNP70 ImmunoassayLJM · Traditional | Phadia AB | 11/27/2018SE |
| K151559 | ImmuLisa Enhanced Centromere Antibody ELISALJM · Traditional | Immco Diagnostics, Inc. | 03/11/2016SE |
| K140493 | Elia SCL-70S ImmunoassayLJM · Traditional | Phadia GmbH | 10/30/2014SE |
| K123880 | Quanta Flash CentromereLJM · Traditional | Inova Diagnostics, Inc. | 02/07/2014SE |
| K131330 | Gold Standard Diagnostics Anti-Nuclear Antibody (Ana) Screen Elisa Test KitLJM · Traditional | Gold Standard Diagnostics | 01/28/2014SE |
| K131185 | Ana Screen Elisa (Igg)LJM · Traditional | Euroimmun US | 07/15/2013SE |
| K083188 | Varelisa Recombi Ana Screen, Model 12 596LJM · Traditional | Phadia US, Inc. | 03/13/2009SE |
| K050967 | Varelisa Recombi CTD Screen, Model 13096LJM · Traditional | Sweden Diagnostics (Germany) GmbH | 06/28/2005SE |
| K050625 | Varelisa Recombi Ana Profile, Model 18496LJM · Traditional | Sweden Diagnostics (Germany) GmbH | 04/26/2005SE |
| K041102 | Immulisa Antinuclear Antibody Screen ElisaLJM · Traditional | Immco Diagnostics, Inc. | 10/26/2004SE |
More from Immco Diagnostics, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K003414 | Varelisa TG (Thyroglobulin) Antibodies,JZO · Traditional | 11/27/2000SE |
| K002556 | Ceeon Easysert Intraocular Lens Injector, Model IMP-1MSS · Traditional | 10/31/2000SE |
| K000312 | Varelisa SM AntibodiesLKP · Traditional | 03/17/2000SE |
| K000132 | Allergen Immunocap, Models C74, E89, EX2, EX70, EX71, EX73, FX8, FX9, FX10, FX16, FX73…DHB · Traditional | 02/18/2000SE |
| K993585 | Varelisa Tpo Antibodies, Model 12348/12396JZO · Traditional | 01/05/2000SE |
| K993388 | Allergen Immundocap MODELC5, C6, C73, E201, E213, F50, F51,F54, F55, F56, F57, F58, F59…DHB · Traditional | 12/01/1999SE |
| K993589 | Varelisa RNP AntibodiesLKO · Traditional | 11/26/1999SE |
| K993109 | Varelisa Recombi Ana ProfileLJM · Traditional | 11/12/1999SE |
| K991945 | Pharmacia Cap System Ige Feia, Model 10-9395-01DGC · Traditional | 07/28/1999SE |
| K991048 | Allergen Immunocap, Models E7, F93, F94, F95, F203, F204, F208, F209, F210, F214, F216…DHB · Traditional | 05/14/1999SE |
Questions and answers
When was Varelisa Recombi Ana Screen Eia, Models 128 48/ 128 96 cleared by the FDA?
Varelisa Recombi Ana Screen Eia, Models 128 48/ 128 96 (K993108) received a 510(k) decision of Substantially Equivalent on November 12, 1999, 56 days after the submission was received.
What is the product code of K993108?
The FDA product code is LJM – Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls, a Class II (moderate risk) device regulated under 21 CFR 866.5100.