The following data is part of a premarket notification filed by Good Biotech Corp. with the FDA for Crpex-hs C-reactive Protein Lit Assay, Catalog No. 1010.
| Device ID | K020603 |
| 510k Number | K020603 |
| Device Name: | CRPEX-HS C-REACTIVE PROTEIN LIT ASSAY, CATALOG NO. 1010 |
| 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 | 2002-02-25 |
| Decision Date | 2002-06-13 |
| Summary: | summary |