FDA 510(k) Applications Submitted by DADE INTL., INC.
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K973974 |
10/20/1997 |
DADE TRU-LIQUID CARDIAC CONTROL |
DADE INTL., INC. |
| K970505 |
02/10/1997 |
DADE PFA-100 PLATELET FUNCTION ANALYZER/PFA COLLAGEN/EPINEPHRINE TEST CARTRIDGE/PFA COLLAGEN/ADP TEST CARTRIDGE/ |
DADE INTL., INC. |
| K970330 |
01/28/1997 |
DADE INDIRECT IMT SYSTEM WITH TCO2 ELECTRODE |
DADE INTL., INC. |
| K962817 |
07/19/1996 |
DRUG CALIBRATOR II |
DADE INTL., INC. |
| K962818 |
07/19/1996 |
TOBRAMYCIN FLEX REAGENT CARTRIDGE |
DADE INTL., INC. |
| K962819 |
07/19/1996 |
GENTAMICIN FLEX REAGENT CARTRIDGE |
DADE INTL., INC. |
| K962820 |
07/19/1996 |
CARBAMAZEPINE FLEX REAGENT CARTRIDGE |
DADE INTL., INC. |
| K972782 |
07/25/1997 |
DADE STRATUS CK-MB FLUOROMETRIC ENZYME IMMUNOASSAY |
DADE INTL., INC. |
| K963244 |
08/19/1996 |
ACETAMINOPHEN FLEX REAGENT CARTRIDGE |
DADE INTL., INC. |
| K963267 |
08/20/1996 |
VANCOMYCIN FLEX REAGENT CARTRIDGE |
DADE INTL., INC. |
| K962594 |
07/02/1996 |
ACA PLUS FT4 CALIBRATOR |
DADE INTL., INC. |
| K962602 |
07/02/1996 |
ACA PLUS FREE THYROXINE(FT4) METHOD |
DADE INTL., INC. |
| K964660 |
11/20/1996 |
PARAMAX CHOLESTEROL REAGENT |
DADE INTL., INC. |
| K964715 |
11/25/1996 |
PARAMAX SALICYLATE REAGENT |
DADE INTL., INC. |
| K964565 |
11/14/1996 |
PARAMAX AMMONIA AND AMMONIA BLANK REAGENT |
DADE INTL., INC. |
| K964346 |
10/31/1996 |
PARAMAX TRIGLYCERID REAGENT |
DADE INTL., INC. |
| K960103 |
01/11/1996 |
DADE MONI-TROL CANDIDATE PRODUCT COMBINATIONS |
DADE INTL., INC. |
| K964139 |
10/15/1996 |
SYSMEX CA-6000 |
DADE INTL., INC. |
| K974343 |
11/19/1997 |
DADE INNOVIN |
DADE INTL., INC. |
| K972287 |
06/19/1997 |
DADE TRU-LIQUID BILIRUBIN CONTROL |
DADE INTL., INC. |
| K964862 |
12/04/1996 |
TROPONIN-I TEST SYSTEM |
DADE INTL., INC. |
| K965213 |
12/30/1996 |
STRATUS MYOGLOBIN GLUOROMETRIC ENZYME IMMUNOASSAY |
DADE INTL., INC. |
| K973668 |
09/25/1997 |
CARDIAC TROPONIN-I (TROP) CALIBRATOR |
DADE INTL., INC. |
| K970676 |
02/24/1997 |
DRIED GRAM-NEGATIVE MIC/COMBO PANELS |
DADE INTL., INC. |
| K972524 |
07/07/1997 |
DRIED GRAM-POSITIVE MIC/COMBO PANELS |
DADE INTL., INC. |
| K962150 |
06/04/1996 |
DRIED GRAM-NEGATIVE AND GRAM-POSITIVE MIC/COMBO PANELS |
DADE INTL., INC. |
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