The following data is part of a premarket notification filed by Good Biotech Corp. with the FDA for Duet Hs-crp Lit Assay, Catalog Number: 4010, Duet Hs-crp Calibrator Set, Catalog Number: 4511.
| Device ID | K050713 |
| 510k Number | K050713 |
| Device Name: | DUET HS-CRP LIT ASSAY, CATALOG NUMBER: 4010, DUET HS-CRP CALIBRATOR SET, CATALOG NUMBER: 4511 |
| Classification | System, Test, C-reactive Protein |
| 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 | DCN |
| CFR Regulation Number | 866.5270 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-03-18 |
| Decision Date | 2005-06-06 |
| Summary: | summary |