Company ยท US
Dade, Baxter Travenol Diagnostics, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1976 to 1980. 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 |
|---|---|---|
| JJT | Enzyme Controls (Assayed And Unassayed) | 4 |
| JPK | Mixture, Hematology Quality Control | 3 |
| GJW | Pipette, Pasteur | 2 |
| JJY | Multi-Analyte Controls, All Kinds (Assayed) | 2 |
| JPA | System, Multipurpose For In Vitro Coagulation Studies | 2 |
| KHQ | Radioassay, Triiodothyronine Uptake | 2 |
| CDX | Radioimmunoassay, Total Thyroxine | 1 |
| CET | Olive Oil Emulsion (Turbidimetric), Lipase | 1 |
| DBF | Ferritin, Antigen, Antiserum, Control | 1 |
| DDX | Plasminogen, Antigen, Antiserum, Control | 1 |
| DOG | Radioimmunoassay, Digoxin (125-I), Rabbit Antibody, Polyethylene Glycol | 1 |
| GFO | Activated Partial Thromboplastin | 1 |
| GGK | Products, Red-Cell Lysing Products | 1 |
| GGM | Control, Hemoglobin | 1 |
| GGN | Plasma, Coagulation Control | 1 |
| GJG | Pipette, Quantitative, Hematology | 1 |
| GJP | Control, Platelet | 1 |
| IAF | Wright'S Stain | 1 |
| JBQ | Antithrombin Iii Quantitation | 1 |
| JGY | Colorimetric Method, Triglycerides | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Mar 5, 1980 | K800296 | WHOLE BLOOD GAS CONTROL, LEVELS 1,2,&3 Dade, Baxter Travenol Diagnostics, Inc. | GGM |
| Feb 13, 1980 | K792606 | WHOLE BLOOD PLATELET CONTROL NORMAL, Dade, Baxter Travenol Diagnostics, Inc. | JPK |
| Jan 21, 1980 | K792723 | BLOOD FLUID FILTERS Dade, Baxter Travenol Diagnostics, Inc. | JKA |
| Jan 16, 1980 | K792607 | T3 UPTAKE (T3U) REAGENTS Dade, Baxter Travenol Diagnostics, Inc. | KHQ |
| Dec 27, 1979 | K792443 | TSH RADIOIMMUNOASSAY Dade, Baxter Travenol Diagnostics, Inc. | JLW |
| Dec 18, 1979 | K792442 | FERRITIN RADIOIMMUNOASSAY Dade, Baxter Travenol Diagnostics, Inc. | DBF |
| Nov 27, 1979 | K791922 | HARLECO BRAND CLINICARD LIPASE TEST SET Dade, Baxter Travenol Diagnostics, Inc. | CET |
| Nov 13, 1979 | K792183 | DADE HIGH DENSITY LIPOPROTEIN CHOLESTERO Dade, Baxter Travenol Diagnostics, Inc. | LBS |
| May 23, 1979 | K790776 | DADE LOW IONIC STRENGTH SOLUITION (LISS) Dade, Baxter Travenol Diagnostics, Inc. | KSG |
| May 23, 1979 | K790767 | IMMU-TEK AUTOMATIC CENTRIFUGE Dade, Baxter Travenol Diagnostics, Inc. | KSN |
| Apr 23, 1979 | K790571 | QUIK-STAIN Dade, Baxter Travenol Diagnostics, Inc. | IAF |
| Mar 21, 1979 | K790264 | DATA-TOPE TRI-RAC RADIOASSAY CONTROL Dade, Baxter Travenol Diagnostics, Inc. | JJY |
| Mar 12, 1979 | K790204 | PLASMA, STANDARDIZED NORMAL Dade, Baxter Travenol Diagnostics, Inc. | JPA |
| Feb 15, 1979 | K782150 | FLUROMETER, DADE Dade, Baxter Travenol Diagnostics, Inc. | JZT |
| Feb 15, 1979 | K781479 | HEPARIN ASSAY Dade, Baxter Travenol Diagnostics, Inc. | KFF |
| Jan 17, 1979 | K782098 | REAGENT, LYSING AND HEMOGLOBIN Dade, Baxter Travenol Diagnostics, Inc. | GGK |
| Nov 15, 1978 | K781478 | PLASMINOGEN ASSAY Dade, Baxter Travenol Diagnostics, Inc. | DDX |
| Nov 8, 1978 | K781480 | ANTITHROMBIN III ASSAY Dade, Baxter Travenol Diagnostics, Inc. | JBQ |
| Oct 17, 1978 | K781593 | RIA CONTROLS Dade, Baxter Travenol Diagnostics, Inc. | JJY |
| Jul 27, 1978 | K781077 | CONTROL, HEMATOLOGY, CH-60 Dade, Baxter Travenol Diagnostics, Inc. | JPK |
| Jun 13, 1978 | K780801 | ISOZYME - ID CPK MARKER Dade, Baxter Travenol Diagnostics, Inc. | JJT |
| Mar 3, 1978 | K780208 | ASPIRATOR, MANUEL Dade, Baxter Travenol Diagnostics, Inc. | JQW |
| Mar 2, 1978 | K780281 | IMMUFUGE DISP. LINER Dade, Baxter Travenol Diagnostics, Inc. | KSO |
| Mar 2, 1978 | K780047 | PLATELET AGGREGATING REAGENTS Dade, Baxter Travenol Diagnostics, Inc. | JOZ |
| Oct 19, 1977 | K771740 | CARDIOZYME CK-CONTROL LEVEL 1 Dade, Baxter Travenol Diagnostics, Inc. | JJT |
| Aug 26, 1977 | K770974 | CARDIOZYME CK-MB REAGENTS Dade, Baxter Travenol Diagnostics, Inc. | |
| Aug 25, 1977 | K771588 | PLATELET CONTROLS NORMAL & ABNORMAL Dade, Baxter Travenol Diagnostics, Inc. | GJP |
| Aug 22, 1977 | K771346 | CI-TROL COAGULATION CONTROLS II & III Dade, Baxter Travenol Diagnostics, Inc. | GGN |
| Aug 4, 1977 | K771138 | PIPETS BOROSILICATE GLASS Dade, Baxter Travenol Diagnostics, Inc. | GJW |
| Aug 4, 1977 | K771137 | PIPETS UNIFORM DROP SIZE BOROSILICATE Dade, Baxter Travenol Diagnostics, Inc. | GJW |
| Aug 4, 1977 | K770973 | CARDIOZYME CK CONTROL NORMAL Dade, Baxter Travenol Diagnostics, Inc. | JJT |
| Aug 4, 1977 | K770971 | CARDIOZYME CK-CONTROL ABNORMAL Dade, Baxter Travenol Diagnostics, Inc. | JJT |
| Aug 2, 1977 | K770950 | WHOLE BLOOD GAS CONTROL Dade, Baxter Travenol Diagnostics, Inc. | JJS |
| Jul 15, 1977 | K770972 | CARDIOZYME CK-TOTAL REAGENTS Dade, Baxter Travenol Diagnostics, Inc. | |
| Feb 24, 1977 | K761283 | TRI-CON TRIGLYCERIDGE REAGENTS Dade, Baxter Travenol Diagnostics, Inc. | JGY |
| Feb 9, 1977 | K761281 | DATA-TOPE T3 UPTAKE PROCEDURE Dade, Baxter Travenol Diagnostics, Inc. | KHQ |
| Jan 25, 1977 | K761284 | UNIVAL CONTROL CELLS Dade, Baxter Travenol Diagnostics, Inc. | KSF |
| Dec 30, 1976 | K761303 | IMMU-SAL IMMUNOHEMATOLOGICAL SALINE Dade, Baxter Travenol Diagnostics, Inc. | KSS |
| Dec 30, 1976 | K761282 | DATA-TOPE T4 RIA PROCEDURE Dade, Baxter Travenol Diagnostics, Inc. | CDX |
| Nov 24, 1976 | K760594 | AUTO-FI COAGULATION INSTRUMENT Dade, Baxter Travenol Diagnostics, Inc. | JPA |
| Oct 29, 1976 | K760719 | UNIFORM DROP SIZE PASTEUR TYPE PIPETS Dade, Baxter Travenol Diagnostics, Inc. | GJG |
| Oct 8, 1976 | K760549 | PLATELET CONTROLS, NORMAL & ABNORMAL Dade, Baxter Travenol Diagnostics, Inc. | JPK |
| Aug 23, 1976 | K760416 | DATA-TOPE SYSTEM DIGOXIN RIA Dade, Baxter Travenol Diagnostics, Inc. | DOG |
| Aug 3, 1976 | K760318 | ACTIN, ACTIVATED CEPHALOPLASTIN REAGENT Dade, Baxter Travenol Diagnostics, Inc. | GFO |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||