Company ยท US
Hyland Therapeutic Div., Travenol Laboratories
FDA 510(k) clearances and medical device recalls filed under this name, 1976 to 1982. Name variants (Inc, Corp, punctuation) are merged.
44510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| JIX | Calibrator, Multi-Analyte Mixture | 3 |
| DAK | Complement C1q, Antigen, Antiserum, Control | 2 |
| DIF | Drug Mixture Control Materials | 2 |
| GFO | Activated Partial Thromboplastin | 2 |
| LGO | Test, Leukocyte Typing | 2 |
| CEE | Radioimmunoassay, Thyroxine-Binding Globulin | 1 |
| CFN | Method, Nephelometric, Immunoglobulins (G, A, M) | 1 |
| CZJ | Igd, Antigen, Antiserum, Control | 1 |
| DBA | Complement C1 Inhibitor (Inactivator), Antigen, Antiserum, Control | 1 |
| DCN | System, Test, C-Reactive Protein | 1 |
| DDB | Ceruloplasmin, Antigen, Antiserum, Control | 1 |
| DDX | Plasminogen, Antigen, Antiserum, Control | 1 |
| DEB | Alpha-2-Macroglobulin, Antigen, Antiserum, Control | 1 |
| DEM | Alpha-1-Antitrypsin, Antigen, Antiserum, Control | 1 |
| DEN | Alpha-1-T-Glycoprotein, Antigen, Antiserum, Control | 1 |
| DER | Alpha-1-Lipoprotein, Antigen, Antiserum, Control | 1 |
| DFC | Lipoprotein, Low-Density, Antigen, Antiserum, Control | 1 |
| DFT | Igm, Antigen, Antiserum, Control | 1 |
| DGC | Ige, Antigen, Antiserum, Control | 1 |
| DHR | System, Test, Rheumatoid Factor | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Apr 26, 1982 | K820835 | ALUMINA SILICA-ACTIVATED PARTIAL THROM Hyland Therapeutic Div., Travenol Laboratories | GFO |
| Mar 11, 1982 | K820192 | HAEMOPHILUS INFLUENZAE TYPE B ANTISERUM Hyland Therapeutic Div., Travenol Laboratories | GRP |
| Aug 18, 1981 | K812220 | NEPHELOMETRIC SOLID TURBIDITY STANDARD Hyland Therapeutic Div., Travenol Laboratories | JIW |
| Feb 2, 1981 | K810078 | Q-PAK THERAPEUTIC DRUG MONIT. CONTROL S Hyland Therapeutic Div., Travenol Laboratories | DIF |
| Jan 28, 1981 | K810077 | OMEGA THERAPEUTIC DRUG MONIT. CONTROL S. Hyland Therapeutic Div., Travenol Laboratories | DIF |
| Jan 5, 1981 | K802610 | ALERT A,HDL-APOLIPOROTEIN A, TEST KIT Hyland Therapeutic Div., Travenol Laboratories | DER |
| Jun 28, 1979 | K791113 | LOW IONIC STRENGTH SOLUTION (LISS) Hyland Therapeutic Div., Travenol Laboratories | KSG |
| May 16, 1979 | K790249 | TEST CELLS Hyland Therapeutic Div., Travenol Laboratories | KSF |
| Aug 31, 1978 | K781225 | GLOBULIN TEST, HUMAN THYROXINE BINDING Hyland Therapeutic Div., Travenol Laboratories | CEE |
| Jul 27, 1978 | K780962 | AUTOMATED ENZYME Hyland Therapeutic Div., Travenol Laboratories | KSK |
| Jun 14, 1978 | K780785 | DILUTOR TRANSPORTER Hyland Therapeutic Div., Travenol Laboratories | JQW |
| Jun 6, 1978 | K780753 | LAS-R HUMAN IGE TEST Hyland Therapeutic Div., Travenol Laboratories | DGC |
| May 18, 1978 | K780729 | LAS-R HUMAN COMPLEMENT CLQ TEST Hyland Therapeutic Div., Travenol Laboratories | DAK |
| Mar 27, 1978 | K780203 | THROMBOPLASTIN DRIED Hyland Therapeutic Div., Travenol Laboratories | GJS |
| Mar 22, 1978 | K780335 | LAS-R HUMAN C1 ESTERASE INHIBITOR TEST Hyland Therapeutic Div., Travenol Laboratories | DBA |
| Mar 3, 1978 | K780204 | CHEMISTRY CONTROL & REFERENCE SERUMS Hyland Therapeutic Div., Travenol Laboratories | JJT |
| Feb 28, 1978 | K772327 | LAS-R HUMAN IGD TEST Hyland Therapeutic Div., Travenol Laboratories | CZJ |
| Feb 3, 1978 | K772329 | LAS-R HUMAN PREALBUMIN TEST Hyland Therapeutic Div., Travenol Laboratories | JZJ |
| Feb 3, 1978 | K772328 | LAS-R HUMAN ANTITHROMBIN III TEST Hyland Therapeutic Div., Travenol Laboratories | JBQ |
| Jan 24, 1978 | K772085 | LAS-R HUMAN PLASMINOGEN TEST Hyland Therapeutic Div., Travenol Laboratories | DDX |
| Jan 24, 1978 | K772084 | LAS-R HUMAN C3 PROACTIVATOR TEST Hyland Therapeutic Div., Travenol Laboratories | JZH |
| Dec 14, 1977 | K771445 | HERPES I.D. TM TEST Hyland Therapeutic Div., Travenol Laboratories | GQL |
| Nov 14, 1977 | K771795 | LAS-R CERULOPLASMIN TEST Hyland Therapeutic Div., Travenol Laboratories | DDB |
| Nov 11, 1977 | K771700 | TMA BICARBONATE/GLYCEROL DILUENT Hyland Therapeutic Div., Travenol Laboratories | |
| Oct 19, 1977 | K771912 | LAS-R BETA LIPOPROTEIN TEST Hyland Therapeutic Div., Travenol Laboratories | DFC |
| Oct 19, 1977 | K771879 | GLYCOPROTEIN TEST, LAS-R HUMAN 1-ACID Hyland Therapeutic Div., Travenol Laboratories | DEN |
| Oct 4, 1977 | K771780 | LAS-R TM Hyland Therapeutic Div., Travenol Laboratories | DEB |
| Sep 2, 1977 | K771535 | LAS-R HUMAN CRP TEST Hyland Therapeutic Div., Travenol Laboratories | DCN |
| Aug 30, 1977 | K771552 | LAS-R RHEUMATOID FACTOR TEST Hyland Therapeutic Div., Travenol Laboratories | DHR |
| Aug 10, 1977 | K771446 | TRANSPORTEO MODULE Hyland Therapeutic Div., Travenol Laboratories | JQX |
| Jul 21, 1977 | K771226 | LAS-R TEST PROGRAM Hyland Therapeutic Div., Travenol Laboratories | CFN |
| Jul 15, 1977 | K771044 | TMA BICARBONATE DILUENT Hyland Therapeutic Div., Travenol Laboratories | JJS |
| May 3, 1977 | K770547 | LAS-R TM HUMAN COMPLEMENT C4 TEST Hyland Therapeutic Div., Travenol Laboratories | DAK |
| Apr 18, 1977 | K770012 | Q-PAK CHEMISTRY RADIORECEPTOR CONTROL C Hyland Therapeutic Div., Travenol Laboratories | JIX |
| Apr 18, 1977 | K770011 | Q-PAK CHEMISTRY RADIORECEPTOR CONTROL B Hyland Therapeutic Div., Travenol Laboratories | JIX |
| Apr 18, 1977 | K770010 | Q-PAK CHEMISTRY RADIORECEPTOR CONTROL A Hyland Therapeutic Div., Travenol Laboratories | JIX |
| Apr 15, 1977 | K770548 | IMMUNOPLATE III RADIO IMMUNODIFFUSION Hyland Therapeutic Div., Travenol Laboratories | JZQ |
| Apr 6, 1977 | K761009 | LYMPHOCYTE TYPING, POSITIVE CONTROL Hyland Therapeutic Div., Travenol Laboratories | LGO |
| Apr 6, 1977 | K761008 | LYMPHOCYTE TYPING, NEGATIVE CONTROL Hyland Therapeutic Div., Travenol Laboratories | LGO |
| Jan 10, 1977 | K760918 | HEPARIN CONTROL PLASMA Hyland Therapeutic Div., Travenol Laboratories | GFO |
| Dec 30, 1976 | K760917 | LAS-R HUMAN HAPTOGLOBIN TEST Hyland Therapeutic Div., Travenol Laboratories | DFT |
| Nov 16, 1976 | K760916 | LAS-R HUMAN ALPHA, ANTITRYPSIN TEST Hyland Therapeutic Div., Travenol Laboratories | DEM |
| Nov 5, 1976 | K760818 | TRIS BICARBONATE DILUENT Hyland Therapeutic Div., Travenol Laboratories | JJY |
| Oct 29, 1976 | K760499 | REAGENT, PARTIAL THROMBOPLASTIN Hyland Therapeutic Div., Travenol Laboratories |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||