FDA 510(k) Applications for Medical Device Product Code "DDZ"
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FDA 510(k) Number | Applicant | Device Name | Decision Date |
K050576 | GOOD BIOTECH CORP. | MICROALBUMIN TIA REAGENT; MALB CALIBRATOR SET 200; MALB CONTROL-L, CONTROL-H | 04/21/2005 |
K023860 | POINTE SCIENTIFIC, INC. | MICROALBUMIN REAGENT SET AND CALIBRATORS | 04/28/2003 |
K002674 | RANDOX LABORATORIES, LTD. | RANDOX MICROALBUMIN | 10/05/2000 |