Texas Immunology, Inc.
Mchenry, IL, US
Texas Immunology, Inc. appears in FDA device records in Mchenry, IL. FDA records list 27 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 27
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 27 510(k) clearances for Texas Immunology, Inc. between 1982 and 1999. The busiest year on record is 1982, with 6. The most recent is 1999, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1982 | 6 |
| 1983 | 1 |
| 1985 | 1 |
| 1986 | 3 |
| 1988 | 5 |
| 1989 | 3 |
| 1990 | 1 |
| 1991 | 2 |
| 1997 | 3 |
| 1998 | 1 |
| 1999 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K991465 | DRUG STOP | MVO | Substantially Equivalent | |
| K980153 | DRUG CHECK | DIO | Substantially Equivalent | |
| K973208 | FIRST SIGN | LCX | Substantially Equivalent | |
| K972094 | TARGET CARDIAC TROPONIN I TEST | MMI | Substantially Equivalent | |
| K963680 | TARGET MYOGLOBIN TEST | DDR | Substantially Equivalent | |
| K912246 | TARGET MICROALBUMINURIA TEST | JIR | Substantially Equivalent | |
| K910073 | TARGET ASO TEST | GTQ | Substantially Equivalent | |
| K904105 | V-TREND TARGET RF TEST | DHR | Substantially Equivalent | |
| K892231 | V-TREND TARGET CRP TEST | DCN | Substantially Equivalent | |
| K890423 | V-TREND TARGET CRP TEST | DCK | Substantially Equivalent | |
| K890041 | V-TREND TARGET IM TEST | KTN | Substantially Equivalent | |
| K880483 | V-TREND STREP A TEST | GTZ | Substantially Equivalent | |
| K880399 | V-TREND IM DRY-SPOT TEST | KTN | Substantially Equivalent | |
| K875180 | V-TREND RPRL CARD TEST | GMP | Substantially Equivalent | |
| K875262 | V-TREND BETA-HCG DRY-SPOT TEST | JHJ | Substantially Equivalent | |
| K874638 | V-TREND BETA-HCG TEST | JHJ | Substantially Equivalent | |
| K862817 | V-TREND QC TDM CONTROL SERUM 1,2,3. | DIF | Substantially Equivalent | |
| K861756 | V-TREND QC URINE CHEMISTRY CONTROLS LEVEL, I & II | JJW | Substantially Equivalent | |
| K855220 | V-TREND KIT STAPH LATEX TEST | JWX | Substantially Equivalent | |
| K853857 | V-TREND ASO PLUS LATEX TEST | GTQ | Substantially Equivalent | |
| K831597 | SERO/TEX RED CELL RF TEST | DHR | Substantially Equivalent | |
| K822540 | COUNT-10 TROL | JJW | Substantially Equivalent | |
| K821388 | SERO/TEX CRP TEST | DCN | Substantially Equivalent | |
| K821386 | SERO/TEX MONO TEST | KTN | Substantially Equivalent | |
| K821387 | PREG/TEX PREGNANCY TEST | JHJ | Substantially Equivalent | |
| K821385 | SERO/TEX LE TEST | DHC | Substantially Equivalent | |
| K821319 | SERO/TEX RF TEST | DHR | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- JHJAgglutination Method, Human Chorionic Gonadotropin
- GTZAntisera, All Groups, Streptococcus Spp.
- GMPAntisera, Control For Nontreponemal Tests
- GTQAntistreptolysin - Titer/Streptolysin O Reagent
- DCKC-Reactive Protein, Antigen, Antiserum, And Control
- DIFDrug Mixture Control Materials
- DIOEnzyme Immunoassay, Cocaine And Cocaine Metabolites
- MMIImmunoassay Method, Troponin Subunit
- JIRIndicator Method, Protein Or Albumin (Urinary, Non-Quant.)
- JWXKit, Screening, Staphylococcus Aureus
- MVOKit, Test, Multiple, Drugs Of Abuse, Over The Counter
- LCXKit, Test, Pregnancy, Hcg, Over The Counter
- DDRMyoglobin, Antigen, Antiserum, Control
- DCNSystem, Test, C-Reactive Protein
- KTNSystem, Test, Infectious Mononucleosis
- DHRSystem, Test, Rheumatoid Factor
- DHCSystem, Test, Systemic Lupus Erythematosus
- JJWUrinalysis Controls (Assayed And Unassayed)
Recall records
No recall records for this company in the ingested FDA data.
Verification record
There is no verification record for this company. Most companies on this site have none: a record exists only where a company asked to be verified and MDM ran the checks, so the absence of one says nothing about the company.
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Data as of , FDA export datePage updated Source: openFDA, public domain