The following data is part of a premarket notification filed by Good Biotech Corp. with the FDA for Transferrin Tia , Calibrator Set, Control-l,control-m,control-h, Model# Kt-0105-a,ca-0105-a,b,c.
| Device ID | K063766 |
| 510k Number | K063766 |
| Device Name: | TRANSFERRIN TIA , CALIBRATOR SET, CONTROL-L,CONTROL-M,CONTROL-H, MODEL# KT-0105-A,CA-0105-A,B,C |
| Classification | Transferrin, 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 | DDG |
| Subsequent Product Code | JIT |
| Subsequent Product Code | JJX |
| CFR Regulation Number | 866.5880 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-12-20 |
| Decision Date | 2007-04-23 |
| Summary: | summary |