Good Biotech Corp.: FDA filings under this applicant name
FDA lists 8 510(k) clearances under the applicant name “Good Biotech Corp.” (first 2002, latest 2007), across 5 product codes in 2 review panels. Median 510(k) review time under this name: 70 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| DCN | System, Test, C-Reactive Protein | 4 | 4 |
| DBF | Ferritin, Antigen, Antiserum, Control | 1 | 1 |
| DDG | Transferrin, Antigen, Antiserum, Control | 1 | 1 |
| DDZ | Albumin, Fitc, Antigen, Antiserum, Control | 1 | 1 |
| JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | 1 | 1 |
Review panels
- Immunology (7)
- Clinical Chemistry (1)
Most recent Good Biotech Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K063766 | TRANSFERRIN TIA , CALIBRATOR SET, CONTROL-L,CONTROL-M,CONTROL-H, MODEL# KT-0105-A,CA-0105-A,B,C | DDG | 2007-04-23 | 124 |
| K052617 | FERRITIN LIT ASSAY, CATALOG NO. 7010; FERRITIN CALIBRATOR SET, CATALOG NO. 7510; FERRITIN CONTROLS, LEVEL-L & LEVEL-H, | DBF | 2006-02-23 | 153 |
| K050713 | DUET HS-CRP LIT ASSAY, CATALOG NUMBER: 4010, DUET HS-CRP CALIBRATOR SET, CATALOG NUMBER: 4511 | DCN | 2005-06-06 | 80 |
| K050576 | MICROALBUMIN TIA REAGENT; MALB CALIBRATOR SET 200; MALB CONTROL-L, CONTROL-H | DDZ | 2005-04-21 | 45 |
| K022725 | CRPEX CRP CONTROLS LEVEL L, M, H; CAT. NO.: 3011, 3012, 3013 | JJX | 2002-09-23 | 38 |
| K021757 | CRPEX-BR C-REACTIVE PROTEIN LIT ASSAY, CRPEX-BR CRP CALIBRATOR SET | DCN | 2002-07-29 | 61 |
| K021882 | CRPEX-HS CRP CALIBRATOR SET, CATALOG NO: 1510 | DCN | 2002-07-11 | 34 |
| K020603 | CRPEX-HS C-REACTIVE PROTEIN LIT ASSAY, CATALOG NO. 1010 | DCN | 2002-06-13 | 108 |
Recalls
openFDA lists no recalls under a recalling firm named Good Biotech Corp..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Good Clean Love, Inc. (8 510(k)s)
- Good Doctors Co., Ltd. (7 510(k)s)
- Good Sleep CO Pte , Ltd. (3 510(k)s)
- Good Bond Industrial Corp. (2 510(k)s)
- Good Glove Corp. (2 510(k)s)
- Good Medy Enterprise , Ltd. (1 510(k)s)
- Good Methods Global, Inc. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Good Biotech Corp.?
FDA lists 8 510(k) clearances under the applicant name “Good Biotech Corp.” (first 2002, latest 2007), across 5 product codes in 2 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Good Biotech Corp.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Good Biotech Corp. is 70 days.
Which FDA product codes appear under Good Biotech Corp.?
The most frequent FDA product codes under this applicant name are DCN (System, Test, C-Reactive Protein, 4); DBF (Ferritin, Antigen, Antiserum, Control, 1); DDG (Transferrin, Antigen, Antiserum, Control, 1).
Next steps
- See all 8 Good Biotech Corp. clearances with predicates and recalls
- Run predicate analysis for product code DCN, Good Biotech Corp.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.