Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Dade Intl., Inc. — Predicate Candidate Screening
30 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
63 daysmedian FDA review time
196 days90th percentile
30clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K974343 | DADE INNOVIN | Dade Intl., Inc. | 1998-07-22 | 245 | 0 |
| K970505 | DADE PFA-100 PLATELET FUNCTION ANALYZER/PFA COLLAGEN/EPINEPH | Dade Intl., Inc. | 1997-11-17 | 280 | 0 |
| K973974 | DADE TRU-LIQUID CARDIAC CONTROL | Dade Intl., Inc. | 1997-11-06 | 17 | 0 |
| K973668 | CARDIAC TROPONIN-I (TROP) CALIBRATOR | Dade Intl., Inc. | 1997-10-20 | 25 | 0 |
| K972524 | DRIED GRAM-POSITIVE MIC/COMBO PANELS | Dade Intl., Inc. | 1997-09-08 | 63 | 0 |
| K972782 | DADE STRATUS CK-MB FLUOROMETRIC ENZYME IMMUNOASSAY | Dade Intl., Inc. | 1997-08-15 | 21 | 0 |
| K972287 | DADE TRU-LIQUID BILIRUBIN CONTROL | Dade Intl., Inc. | 1997-07-07 | 18 | 0 |
| K964660 | PARAMAX CHOLESTEROL REAGENT | Dade Intl., Inc. | 1997-06-04 | 196 | 0 |
| K970676 | DRIED GRAM-NEGATIVE MIC/COMBO PANELS | Dade Intl., Inc. | 1997-05-02 | 67 | 0 |
| K964715 | PARAMAX SALICYLATE REAGENT | Dade Intl., Inc. | 1997-04-25 | 151 | 0 |
| K970330 | DADE INDIRECT IMT SYSTEM WITH TCO2 ELECTRODE | Dade Intl., Inc. | 1997-04-14 | 76 | 1 |
| K964346 | PARAMAX TRIGLYCERID REAGENT | Dade Intl., Inc. | 1997-03-28 | 148 | 0 |
| K964862 | TROPONIN-I TEST SYSTEM | Dade Intl., Inc. | 1997-02-10 | 68 | 0 |
| K965213 | STRATUS MYOGLOBIN GLUOROMETRIC ENZYME IMMUNOASSAY | Dade Intl., Inc. | 1997-02-10 | 42 | 0 |
| K964139 | SYSMEX CA-6000 | Dade Intl., Inc. | 1997-02-06 | 114 | 0 |
| K964565 | PARAMAX AMMONIA AND AMMONIA BLANK REAGENT | Dade Intl., Inc. | 1996-11-22 | 8 | 0 |
| K963244 | ACETAMINOPHEN FLEX REAGENT CARTRIDGE | Dade Intl., Inc. | 1996-09-23 | 35 | 0 |
| K962817 | DRUG CALIBRATOR II | Dade Intl., Inc. | 1996-09-16 | 59 | 0 |
| K962820 | CARBAMAZEPINE FLEX REAGENT CARTRIDGE | Dade Intl., Inc. | 1996-09-13 | 56 | 0 |
| K962819 | GENTAMICIN FLEX REAGENT CARTRIDGE | Dade Intl., Inc. | 1996-09-13 | 56 | 0 |
| K962818 | TOBRAMYCIN FLEX REAGENT CARTRIDGE | Dade Intl., Inc. | 1996-09-13 | 56 | 0 |
| K963267 | VANCOMYCIN FLEX REAGENT CARTRIDGE | Dade Intl., Inc. | 1996-09-13 | 24 | 0 |
| K962150 | DRIED GRAM-NEGATIVE AND GRAM-POSITIVE MIC/COMBO PANELS | Dade Intl., Inc. | 1996-08-16 | 73 | 0 |
| K962602 | ACA PLUS FREE THYROXINE(FT4) METHOD | Dade Intl., Inc. | 1996-08-15 | 44 | 0 |
| K962594 | ACA PLUS FT4 CALIBRATOR | Dade Intl., Inc. | 1996-08-15 | 44 | 0 |
| K960103 | DADE MONI-TROL CANDIDATE PRODUCT COMBINATIONS | Dade Intl., Inc. | 1996-04-26 | 106 | 0 |
| K952250 | STRATUS CK-MB DENDRIMER FLUOROMETRIC ENZYME IMMUNOASSAY & ST | Dade Intl., Inc. | 1995-07-17 | 63 | 0 |
| K951888 | DADE STRATUS TROPONIN-I CONTROL | Dade Intl., Inc. | 1995-07-13 | 80 | 0 |
| K951890 | STRATUS CARDIAC TROPONIN-I FLUOROMETRIC ENZYME IMMUNMNOASSAY | Dade Intl., Inc. | 1995-07-13 | 80 | 0 |
| K951332 | PARAMAX ALANINE AMINOTRANSFERASE (GPT) REAGENT | Dade Intl., Inc. | 1995-06-19 | 102 | 0 |
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