The following data is part of a premarket notification filed by Good Biotech Corp. with the FDA for Ferritin Lit Assay, Catalog No. 7010; Ferritin Calibrator Set, Catalog No. 7510; Ferritin Controls, Level-l & Level-h,.
| Device ID | K052617 |
| 510k Number | K052617 |
| Device Name: | FERRITIN LIT ASSAY, CATALOG NO. 7010; FERRITIN CALIBRATOR SET, CATALOG NO. 7510; FERRITIN CONTROLS, LEVEL-L & LEVEL-H, |
| Classification | Ferritin, 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 | DBF |
| Subsequent Product Code | JIT |
| Subsequent Product Code | JJX |
| CFR Regulation Number | 866.5340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-09-23 |
| Decision Date | 2006-02-23 |
| Summary: | summary |