Company ยท TW
Good Biotech Corp.
FDA 510(k) clearances and medical device recalls filed under this name, 2002 to 2007. Name variants (Inc, Corp, punctuation) are merged.
8510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Apr 23, 2007 | K063766 | TRANSFERRIN TIA , CALIBRATOR SET, CONTROL-L,CONTROL-M,CONTROL-H, MODEL# KT-0105-A,CA-0105-A,B,C Good Biotech Corp., TW | DDG |
| Feb 23, 2006 | K052617 | FERRITIN LIT ASSAY, CATALOG NO. 7010; FERRITIN CALIBRATOR SET, CATALOG NO. 7510; FERRITIN CONTROLS, LEVEL-L & LEVEL-H, Good Biotech Corp., TW | DBF |
| Jun 6, 2005 | K050713 | DUET HS-CRP LIT ASSAY, CATALOG NUMBER: 4010, DUET HS-CRP CALIBRATOR SET, CATALOG NUMBER: 4511 Good Biotech Corp., TW | DCN |
| Apr 21, 2005 | K050576 | MICROALBUMIN TIA REAGENT; MALB CALIBRATOR SET 200; MALB CONTROL-L, CONTROL-H Good Biotech Corp., TW | DDZ |
| Sep 23, 2002 | K022725 | CRPEX CRP CONTROLS LEVEL L, M, H; CAT. NO.: 3011, 3012, 3013 Good Biotech Corp., TW | JJX |
| Jul 29, 2002 | K021757 | CRPEX-BR C-REACTIVE PROTEIN LIT ASSAY, CRPEX-BR CRP CALIBRATOR SET Good Biotech Corp., TW | DCN |
| Jul 11, 2002 | K021882 | CRPEX-HS CRP CALIBRATOR SET, CATALOG NO: 1510 Good Biotech Corp., CN | DCN |
| Jun 13, 2002 | K020603 | CRPEX-HS C-REACTIVE PROTEIN LIT ASSAY, CATALOG NO. 1010 Good Biotech Corp., TW | DCN |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||