Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Good Biotech Corp. — Predicate Candidate Screening
8 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
80 daysmedian FDA review time
153 days90th percentile
8clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K063766 | TRANSFERRIN TIA , CALIBRATOR SET, CONTROL-L,CONTROL-M,CONTRO | Good Biotech Corp. | 2007-04-23 | 124 | 0 |
| K052617 | FERRITIN LIT ASSAY, CATALOG NO. 7010; FERRITIN CALIBRATOR SE | Good Biotech Corp. | 2006-02-23 | 153 | 0 |
| K050713 | DUET HS-CRP LIT ASSAY, CATALOG NUMBER: 4010, DUET HS-CRP CAL | Good Biotech Corp. | 2005-06-06 | 80 | 0 |
| K050576 | MICROALBUMIN TIA REAGENT; MALB CALIBRATOR SET 200; MALB CONT | Good Biotech Corp. | 2005-04-21 | 45 | 0 |
| K022725 | CRPEX CRP CONTROLS LEVEL L, M, H; CAT. NO.: 3011, 3012, 3013 | Good Biotech Corp. | 2002-09-23 | 38 | 0 |
| K021757 | CRPEX-BR C-REACTIVE PROTEIN LIT ASSAY, CRPEX-BR CRP CALIBRAT | Good Biotech Corp. | 2002-07-29 | 61 | 0 |
| K021882 | CRPEX-HS CRP CALIBRATOR SET, CATALOG NO: 1510 | Good Biotech Corp. | 2002-07-11 | 34 | 0 |
| K020603 | CRPEX-HS C-REACTIVE PROTEIN LIT ASSAY, CATALOG NO. 1010 | Good Biotech Corp. | 2002-06-13 | 108 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda