Company ยท US
Theratest Laboratories, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1991 to 2010. Name variants (Inc, Corp, punctuation) are merged.
22510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| LJM | Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls | 6 |
| DHR | System, Test, Rheumatoid Factor | 3 |
| LLL | Extractable Antinuclear Antibody, Antigen And Control | 2 |
| MSV | System,Test,Antibodies,B2 - Glycoprotein I (B2 - Gpi) | 2 |
| GFO | Activated Partial Thromboplastin | 1 |
| JZO | System, Test, Thyroid Autoantibody | 1 |
| LKJ | Antinuclear Antibody, Antigen, Control | 1 |
| LKP | Anti-Sm Antibody, Antigen And Control | 1 |
| MID | System, Test, Anticardiolipin Immunological | 1 |
| MOB | Test System, Antineutrophil Cytoplasmic Antibodies (Anca) | 1 |
| MQA | Anti-Ribosomal P Antibodies | 1 |
| MVM | Autoantibodies, Endomysial(Tissue Transglutaminase) | 1 |
| NHX | Antibodies, Anti-Cyclic Citrullinated Peptide (Ccp) | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Mar 5, 2010 | K090753 | THERATEST EL-ANTI-CCP/2 Theratest Laboratories, Inc. | NHX |
| Sep 3, 2009 | K090760 | THERATEST EL-ANTI-TPO AND THERATEST EL-ANTI-THYROGLOBULIN, MODEL 104-119, 103-120 Theratest Laboratories, Inc. | JZO |
| Nov 5, 2007 | K071692 | THERATEST EL-TTG IGA/IGG AND THERATEST EL-GLIA IGA/IGG TEST SYSTEMS Theratest Laboratories, Inc. | MVM |
| Jul 20, 2006 | K061376 | EL-ANCA: ANTI-MPO, ANTI-PR3, ANTI-MPO AND ANTI-PR3 Theratest Laboratories, Inc. | MOB |
| Feb 7, 2006 | K060176 | EL-ACL SCREEN; EL-ACL IGM, IGG, IGA Theratest Laboratories, Inc. | MID |
| Oct 7, 2005 | K051066 | THERATEST EL-ANA PROFILES Theratest Laboratories, Inc. | LKP |
| Mar 11, 2004 | K040291 | EL-ANA PROFILES: ANTI-CHROMATIN Theratest Laboratories, Inc. | LJM |
| Feb 6, 2003 | K024151 | EL-ANA PROFILES: ANTI-RIBOSOMAL PROTEIN P Theratest Laboratories, Inc. | MQA |
| Feb 6, 2003 | K024031 | THE THERATEST EL-ANA PROFILES: ANTI-CENTROMERE Theratest Laboratories, Inc. | LJM |
| Sep 12, 2000 | K002559 | EL-ANA PROFILES-2K1 Theratest Laboratories, Inc. | LJM |
| Aug 13, 1998 | K982622 | EL-ANA PROFILES: EL-ENA/5 Theratest Laboratories, Inc. | LLL |
| Aug 13, 1998 | K982150 | EL-ANA PROFILES: EL-ENA/4 Theratest Laboratories, Inc. | LLL |
| Dec 5, 1997 | K973882 | EL-B2GP1SCR Theratest Laboratories, Inc. | MSV |
| Dec 5, 1997 | K972790 | THE THERATEST EL-B2GP1 (IGM, IGG, IGA) AND EL-B2GP1SCR Theratest Laboratories, Inc. | MSV |
| Dec 16, 1996 | K962050 | THERATEST EL-RFSCR Theratest Laboratories, Inc. | DHR |
| Mar 6, 1996 | K955481 | THERATEST KIT (MODIFICATION) Theratest Laboratories, Inc. | LJM |
| Nov 14, 1995 | K954106 | THERATEST LAB, INC., EL-ANASCR KIT Theratest Laboratories, Inc. | LJM |
| Sep 26, 1995 | K950716 | THERATEST EL-ANA PROFILES TEST SYSTEM Theratest Laboratories, Inc. | LJM |
| Jul 28, 1995 | K941398 | EL-RF/3 (IGM-IGG-IGA) KIT Theratest Laboratories, Inc. | DHR |
| Jan 28, 1994 | K933712 | EL-RF TEST SYSTEM: EL-RF-IGM KIT Theratest Laboratories, Inc. | DHR |
| May 22, 1992 | K914454 | THE THERATEST EL-ANA PROFILES Theratest Laboratories, Inc. | LKJ |
| Jan 14, 1991 | K905301 | THE THERATEST ACA TEST Theratest Laboratories, Inc. | GFO |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||