The following data is part of a premarket notification filed by Good Biotech Corp. with the FDA for Microalbumin Tia Reagent; Malb Calibrator Set 200; Malb Control-l, Control-h.
Device ID | K050576 |
510k Number | K050576 |
Device Name: | MICROALBUMIN TIA REAGENT; MALB CALIBRATOR SET 200; MALB CONTROL-L, CONTROL-H |
Classification | Albumin, Fitc, Antigen, Antiserum, Control |
Applicant | GOOD BIOTECH CORP. 38, 34TH RD. TAICHUNG INDUSTRIAL PARK Taichung, TW 407 |
Contact | Victor Chiou |
Correspondent | Victor Chiou GOOD BIOTECH CORP. 38, 34TH RD. TAICHUNG INDUSTRIAL PARK Taichung, TW 407 |
Product Code | DDZ |
Subsequent Product Code | JIT |
Subsequent Product Code | JJX |
CFR Regulation Number | 866.5040 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2005-03-07 |
Decision Date | 2005-04-21 |
Summary: | summary |