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 |