Hyland Therapeutic Div., Travenol Laboratories
Mchenry, IL, US
Hyland Therapeutic Div., Travenol Laboratories appears in FDA device records in Mchenry, IL. FDA records list 44 510(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
- 44
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 44 510(k) clearances for Hyland Therapeutic Div., Travenol Laboratories between 1976 and 1982. The busiest year on record is 1977, with 19. The most recent is 1982, with 2.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1976 | 4 |
| 1977 | 19 |
| 1978 | 13 |
| 1979 | 2 |
| 1981 | 4 |
| 1982 | 2 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K820835 | ALUMINA SILICA-ACTIVATED PARTIAL THROM | GFO | Substantially Equivalent | |
| K820192 | HAEMOPHILUS INFLUENZAE TYPE B ANTISERUM | GRP | Substantially Equivalent | |
| K812220 | NEPHELOMETRIC SOLID TURBIDITY STANDARD | JIW | Substantially Equivalent | |
| K810078 | Q-PAK THERAPEUTIC DRUG MONIT. CONTROL S | DIF | Substantially Equivalent | |
| K810077 | OMEGA THERAPEUTIC DRUG MONIT. CONTROL S. | DIF | Substantially Equivalent | |
| K802610 | ALERT A,HDL-APOLIPOROTEIN A, TEST KIT | DER | Substantially Equivalent | |
| K791113 | LOW IONIC STRENGTH SOLUTION (LISS) | KSG | Substantially Equivalent | |
| K790249 | TEST CELLS | KSF | Substantially Equivalent | |
| K781225 | GLOBULIN TEST, HUMAN THYROXINE BINDING | CEE | Substantially Equivalent | |
| K780962 | AUTOMATED ENZYME | KSK | Substantially Equivalent | |
| K780785 | DILUTOR TRANSPORTER | JQW | Substantially Equivalent | |
| K780753 | LAS-R HUMAN IGE TEST | DGC | Substantially Equivalent | |
| K780729 | LAS-R HUMAN COMPLEMENT CLQ TEST | DAK | Substantially Equivalent | |
| K780203 | THROMBOPLASTIN DRIED | GJS | Substantially Equivalent | |
| K780335 | LAS-R HUMAN C1 ESTERASE INHIBITOR TEST | DBA | Substantially Equivalent | |
| K780204 | CHEMISTRY CONTROL & REFERENCE SERUMS | JJT | Substantially Equivalent | |
| K772327 | LAS-R HUMAN IGD TEST | CZJ | Substantially Equivalent | |
| K772329 | LAS-R HUMAN PREALBUMIN TEST | JZJ | Substantially Equivalent | |
| K772328 | LAS-R HUMAN ANTITHROMBIN III TEST | JBQ | Substantially Equivalent | |
| K772085 | LAS-R HUMAN PLASMINOGEN TEST | DDX | Substantially Equivalent | |
| K772084 | LAS-R HUMAN C3 PROACTIVATOR TEST | JZH | Substantially Equivalent | |
| K771445 | HERPES I.D. TM TEST | GQL | Substantially Equivalent | |
| K771795 | LAS-R CERULOPLASMIN TEST | DDB | Substantially Equivalent | |
| K771700 | TMA BICARBONATE/GLYCEROL DILUENT | Substantially Equivalent | ||
| K771912 | LAS-R BETA LIPOPROTEIN TEST | DFC | Substantially Equivalent | |
| K771879 | GLYCOPROTEIN TEST, LAS-R HUMAN 1-ACID | DEN | Substantially Equivalent | |
| K771780 | LAS-R TM | DEB | Substantially Equivalent | |
| K771535 | LAS-R HUMAN CRP TEST | DCN | Substantially Equivalent | |
| K771552 | LAS-R RHEUMATOID FACTOR TEST | DHR | Substantially Equivalent | |
| K771446 | TRANSPORTEO MODULE | JQX | Substantially Equivalent | |
| K771226 | LAS-R TEST PROGRAM | CFN | Substantially Equivalent | |
| K771044 | TMA BICARBONATE DILUENT | JJS | Substantially Equivalent | |
| K770547 | LAS-R TM HUMAN COMPLEMENT C4 TEST | DAK | Substantially Equivalent | |
| K770012 | Q-PAK CHEMISTRY RADIORECEPTOR CONTROL C | JIX | Substantially Equivalent | |
| K770011 | Q-PAK CHEMISTRY RADIORECEPTOR CONTROL B | JIX | Substantially Equivalent | |
| K770010 | Q-PAK CHEMISTRY RADIORECEPTOR CONTROL A | JIX | Substantially Equivalent | |
| K770548 | IMMUNOPLATE III RADIO IMMUNODIFFUSION | JZQ | Substantially Equivalent | |
| K761009 | LYMPHOCYTE TYPING, POSITIVE CONTROL | LGO | Substantially Equivalent | |
| K761008 | LYMPHOCYTE TYPING, NEGATIVE CONTROL | LGO | Substantially Equivalent | |
| K760918 | HEPARIN CONTROL PLASMA | GFO | Substantially Equivalent | |
| K760917 | LAS-R HUMAN HAPTOGLOBIN TEST | DFT | Substantially Equivalent | |
| K760916 | LAS-R HUMAN ALPHA, ANTITRYPSIN TEST | DEM | Substantially Equivalent | |
| K760818 | TRIS BICARBONATE DILUENT | JJY | Substantially Equivalent | |
| K760499 | REAGENT, PARTIAL THROMBOPLASTIN | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- GFOActivated Partial Thromboplastin
- DEMAlpha-1-Antitrypsin, Antigen, Antiserum, Control
- DERAlpha-1-Lipoprotein, Antigen, Antiserum, Control
- DENAlpha-1-T-Glycoprotein, Antigen, Antiserum, Control
- DEBAlpha-2-Macroglobulin, Antigen, Antiserum, Control
- GRPAntisera, All Types, H. Influenza
- GQLAntisera, Fluorescent, Herpesvirus Hominis 1,2
- JBQAntithrombin Iii Quantitation
- JIXCalibrator, Multi-Analyte Mixture
- JIWCalibrator, Surrogate
- DDBCeruloplasmin, Antigen, Antiserum, Control
- DBAComplement C1 Inhibitor (Inactivator), Antigen, Antiserum, Control
- DAKComplement C1q, Antigen, Antiserum, Control
- JJSControls For Blood-Gases, (Assayed And Unassayed)
- DIFDrug Mixture Control Materials
- JJTEnzyme Controls (Assayed And Unassayed)
- JZHFactor B, Antigen, Antiserum, Control
- CZJIgd, Antigen, Antiserum, Control
- DGCIge, Antigen, Antiserum, Control
- DFTIgm, Antigen, Antiserum, Control
- KSFKit, Quality Control For Blood Banking Reagents
- DFCLipoprotein, Low-Density, Antigen, Antiserum, Control
- KSGMedia, Potentiating For In Vitro Diagnostic Use
- CFNMethod, Nephelometric, Immunoglobulins (G, A, M)
- JJYMulti-Analyte Controls, All Kinds (Assayed)
- JQXNephelometer, For Clinical Use
- DDXPlasminogen, Antigen, Antiserum, Control
- JZQPlates And Equipment, Radial Immunodiffusion
- JZJPrealbumin, Antigen, Antiserum, Control
- CEERadioimmunoassay, Thyroxine-Binding Globulin
- KSKSolution, Stabilized Enzyme
- JQWStation, Pipetting And Diluting, For Clinical Use
- DCNSystem, Test, C-Reactive Protein
- DHRSystem, Test, Rheumatoid Factor
- LGOTest, Leukocyte Typing
- GJSTest, Time, Prothrombin
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain