Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Dade, Baxter Travenol Diagnostics, Inc. — Predicate Candidate Screening
44 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
34 daysmedian FDA review time
72 days90th percentile
44clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K800296 | WHOLE BLOOD GAS CONTROL, LEVELS 1,2,&3 | Dade, Baxter Travenol Diagnostics, Inc. | 1980-03-05 | 23 | 0 |
| K792606 | WHOLE BLOOD PLATELET CONTROL NORMAL, | Dade, Baxter Travenol Diagnostics, Inc. | 1980-02-13 | 57 | 0 |
| K792723 | BLOOD FLUID FILTERS | Dade, Baxter Travenol Diagnostics, Inc. | 1980-01-21 | 21 | 0 |
| K792607 | T3 UPTAKE (T3U) REAGENTS | Dade, Baxter Travenol Diagnostics, Inc. | 1980-01-16 | 29 | 0 |
| K792443 | TSH RADIOIMMUNOASSAY | Dade, Baxter Travenol Diagnostics, Inc. | 1979-12-27 | 28 | 0 |
| K792442 | FERRITIN RADIOIMMUNOASSAY | Dade, Baxter Travenol Diagnostics, Inc. | 1979-12-18 | 19 | 0 |
| K791922 | HARLECO BRAND CLINICARD LIPASE TEST SET | Dade, Baxter Travenol Diagnostics, Inc. | 1979-11-27 | 62 | 0 |
| K792183 | DADE HIGH DENSITY LIPOPROTEIN CHOLESTERO | Dade, Baxter Travenol Diagnostics, Inc. | 1979-11-13 | 15 | 0 |
| K790776 | DADE LOW IONIC STRENGTH SOLUITION (LISS) | Dade, Baxter Travenol Diagnostics, Inc. | 1979-05-23 | 33 | 0 |
| K790767 | IMMU-TEK AUTOMATIC CENTRIFUGE | Dade, Baxter Travenol Diagnostics, Inc. | 1979-05-23 | 34 | 0 |
| K790571 | QUIK-STAIN | Dade, Baxter Travenol Diagnostics, Inc. | 1979-04-23 | 31 | 0 |
| K790264 | DATA-TOPE TRI-RAC RADIOASSAY CONTROL | Dade, Baxter Travenol Diagnostics, Inc. | 1979-03-21 | 43 | 0 |
| K790204 | PLASMA, STANDARDIZED NORMAL | Dade, Baxter Travenol Diagnostics, Inc. | 1979-03-12 | 41 | 0 |
| K782150 | FLUROMETER, DADE | Dade, Baxter Travenol Diagnostics, Inc. | 1979-02-15 | 51 | 0 |
| K781479 | HEPARIN ASSAY | Dade, Baxter Travenol Diagnostics, Inc. | 1979-02-15 | 171 | 0 |
| K782098 | REAGENT, LYSING AND HEMOGLOBIN | Dade, Baxter Travenol Diagnostics, Inc. | 1979-01-17 | 30 | 0 |
| K781478 | PLASMINOGEN ASSAY | Dade, Baxter Travenol Diagnostics, Inc. | 1978-11-15 | 79 | 0 |
| K781480 | ANTITHROMBIN III ASSAY | Dade, Baxter Travenol Diagnostics, Inc. | 1978-11-08 | 72 | 0 |
| K781593 | RIA CONTROLS | Dade, Baxter Travenol Diagnostics, Inc. | 1978-10-17 | 29 | 0 |
| K781077 | CONTROL, HEMATOLOGY, CH-60 | Dade, Baxter Travenol Diagnostics, Inc. | 1978-07-27 | 29 | 0 |
| K780801 | ISOZYME - ID CPK MARKER | Dade, Baxter Travenol Diagnostics, Inc. | 1978-06-13 | 33 | 0 |
| K780208 | ASPIRATOR, MANUEL | Dade, Baxter Travenol Diagnostics, Inc. | 1978-03-03 | 24 | 0 |
| K780047 | PLATELET AGGREGATING REAGENTS | Dade, Baxter Travenol Diagnostics, Inc. | 1978-03-02 | 52 | 0 |
| K780281 | IMMUFUGE DISP. LINER | Dade, Baxter Travenol Diagnostics, Inc. | 1978-03-02 | 9 | 0 |
| K771740 | CARDIOZYME CK-CONTROL LEVEL 1 | Dade, Baxter Travenol Diagnostics, Inc. | 1977-10-19 | 34 | 0 |
| K770974 | CARDIOZYME CK-MB REAGENTS | Dade, Baxter Travenol Diagnostics, Inc. | 1977-08-26 | 87 | 0 |
| K771588 | PLATELET CONTROLS NORMAL & ABNORMAL | Dade, Baxter Travenol Diagnostics, Inc. | 1977-08-25 | 7 | 0 |
| K771346 | CI-TROL COAGULATION CONTROLS II & III | Dade, Baxter Travenol Diagnostics, Inc. | 1977-08-22 | 33 | 0 |
| K770973 | CARDIOZYME CK CONTROL NORMAL | Dade, Baxter Travenol Diagnostics, Inc. | 1977-08-04 | 65 | 0 |
| K770971 | CARDIOZYME CK-CONTROL ABNORMAL | Dade, Baxter Travenol Diagnostics, Inc. | 1977-08-04 | 65 | 0 |
| K771137 | PIPETS UNIFORM DROP SIZE BOROSILICATE | Dade, Baxter Travenol Diagnostics, Inc. | 1977-08-04 | 41 | 0 |
| K771138 | PIPETS BOROSILICATE GLASS | Dade, Baxter Travenol Diagnostics, Inc. | 1977-08-04 | 41 | 0 |
| K770950 | WHOLE BLOOD GAS CONTROL | Dade, Baxter Travenol Diagnostics, Inc. | 1977-08-02 | 69 | 0 |
| K770972 | CARDIOZYME CK-TOTAL REAGENTS | Dade, Baxter Travenol Diagnostics, Inc. | 1977-07-15 | 45 | 0 |
| K761283 | TRI-CON TRIGLYCERIDGE REAGENTS | Dade, Baxter Travenol Diagnostics, Inc. | 1977-02-24 | 66 | 0 |
| K761281 | DATA-TOPE T3 UPTAKE PROCEDURE | Dade, Baxter Travenol Diagnostics, Inc. | 1977-02-09 | 51 | 0 |
| K761284 | UNIVAL CONTROL CELLS | Dade, Baxter Travenol Diagnostics, Inc. | 1977-01-25 | 36 | 0 |
| K761303 | IMMU-SAL IMMUNOHEMATOLOGICAL SALINE | Dade, Baxter Travenol Diagnostics, Inc. | 1976-12-30 | 8 | 0 |
| K761282 | DATA-TOPE T4 RIA PROCEDURE | Dade, Baxter Travenol Diagnostics, Inc. | 1976-12-30 | 10 | 0 |
| K760594 | AUTO-FI COAGULATION INSTRUMENT | Dade, Baxter Travenol Diagnostics, Inc. | 1976-11-24 | 78 | 0 |
| K760719 | UNIFORM DROP SIZE PASTEUR TYPE PIPETS | Dade, Baxter Travenol Diagnostics, Inc. | 1976-10-29 | 32 | 0 |
| K760549 | PLATELET CONTROLS, NORMAL & ABNORMAL | Dade, Baxter Travenol Diagnostics, Inc. | 1976-10-08 | 39 | 0 |
| K760416 | DATA-TOPE SYSTEM DIGOXIN RIA | Dade, Baxter Travenol Diagnostics, Inc. | 1976-08-23 | 14 | 0 |
| K760318 | ACTIN, ACTIVATED CEPHALOPLASTIN REAGENT | Dade, Baxter Travenol Diagnostics, Inc. | 1976-08-03 | 8 | 1 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda