Company ยท US
Texas Immunology, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1982 to 1999. Name variants (Inc, Corp, punctuation) are merged.
27510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| DHR | System, Test, Rheumatoid Factor | 3 |
| JHJ | Agglutination Method, Human Chorionic Gonadotropin | 3 |
| KTN | System, Test, Infectious Mononucleosis | 3 |
| DCN | System, Test, C-Reactive Protein | 2 |
| GTQ | Antistreptolysin - Titer/Streptolysin O Reagent | 2 |
| JJW | Urinalysis Controls (Assayed And Unassayed) | 2 |
| DCK | C-Reactive Protein, Antigen, Antiserum, And Control | 1 |
| DDR | Myoglobin, Antigen, Antiserum, Control | 1 |
| DHC | System, Test, Systemic Lupus Erythematosus | 1 |
| DIF | Drug Mixture Control Materials | 1 |
| DIO | Enzyme Immunoassay, Cocaine And Cocaine Metabolites | 1 |
| GMP | Antisera, Control For Nontreponemal Tests | 1 |
| GTZ | Antisera, All Groups, Streptococcus Spp. | 1 |
| JIR | Indicator Method, Protein Or Albumin (Urinary, Non-Quant.) | 1 |
| JWX | Kit, Screening, Staphylococcus Aureus | 1 |
| LCX | Kit, Test, Pregnancy, Hcg, Over The Counter | 1 |
| MMI | Immunoassay Method, Troponin Subunit | 1 |
| MVO | Kit, Test, Multiple, Drugs Of Abuse, Over The Counter | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Dec 10, 1999 | K991465 | DRUG STOP Texas Immunology, Inc. | MVO |
| Mar 27, 1998 | K980153 | DRUG CHECK Texas Immunology, Inc. | DIO |
| Oct 20, 1997 | K973208 | FIRST SIGN Texas Immunology, Inc. | LCX |
| Jul 23, 1997 | K972094 | TARGET CARDIAC TROPONIN I TEST Texas Immunology, Inc. | MMI |
| Feb 6, 1997 | K963680 | TARGET MYOGLOBIN TEST Texas Immunology, Inc. | DDR |
| Jul 19, 1991 | K912246 | TARGET MICROALBUMINURIA TEST Texas Immunology, Inc. | JIR |
| May 21, 1991 | K910073 | TARGET ASO TEST Texas Immunology, Inc. | GTQ |
| Oct 15, 1990 | K904105 | V-TREND TARGET RF TEST Texas Immunology, Inc. | DHR |
| Apr 21, 1989 | K892231 | V-TREND TARGET CRP TEST Texas Immunology, Inc. | DCN |
| Feb 17, 1989 | K890423 | V-TREND TARGET CRP TEST Texas Immunology, Inc. | DCK |
| Jan 23, 1989 | K890041 | V-TREND TARGET IM TEST Texas Immunology, Inc. | KTN |
| Apr 12, 1988 | K880483 | V-TREND STREP A TEST Texas Immunology, Inc. | GTZ |
| Feb 17, 1988 | K880399 | V-TREND IM DRY-SPOT TEST Texas Immunology, Inc. | KTN |
| Feb 4, 1988 | K875180 | V-TREND RPRL CARD TEST Texas Immunology, Inc. | GMP |
| Feb 2, 1988 | K875262 | V-TREND BETA-HCG DRY-SPOT TEST Texas Immunology, Inc. | JHJ |
| Jan 21, 1988 | K874638 | V-TREND BETA-HCG TEST Texas Immunology, Inc. | JHJ |
| Aug 19, 1986 | K862817 | V-TREND QC TDM CONTROL SERUM 1,2,3. Texas Immunology, Inc. | DIF |
| Jul 7, 1986 | K861756 | V-TREND QC URINE CHEMISTRY CONTROLS LEVEL, I & II Texas Immunology, Inc. | JJW |
| Mar 3, 1986 | K855220 | V-TREND KIT STAPH LATEX TEST Texas Immunology, Inc. | JWX |
| Oct 16, 1985 | K853857 | V-TREND ASO PLUS LATEX TEST Texas Immunology, Inc. | GTQ |
| Jun 30, 1983 | K831597 | SERO/TEX RED CELL RF TEST Texas Immunology, Inc. | DHR |
| Oct 8, 1982 | K822540 | COUNT-10 TROL Texas Immunology, Inc. | JJW |
| Jul 2, 1982 | K821388 | SERO/TEX CRP TEST Texas Immunology, Inc. | DCN |
| Jul 2, 1982 | K821386 | SERO/TEX MONO TEST Texas Immunology, Inc. | KTN |
| Jun 2, 1982 | K821387 | PREG/TEX PREGNANCY TEST Texas Immunology, Inc. | JHJ |
| May 28, 1982 | K821385 | SERO/TEX LE TEST Texas Immunology, Inc. | DHC |
| May 21, 1982 | K821319 | SERO/TEX RF TEST Texas Immunology, Inc. | DHR |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||