Caltag Laboratories, Inc.: FDA filings under this applicant name
FDA lists 12 510(k) clearances under the applicant name “Caltag Laboratories, Inc.” (first 1995, latest 1999), across 2 product codes in 1 review panel. Median 510(k) review time under this name: 294 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 |
|---|---|---|---|
| GKZ | Counter, Differential Cell | 11 | 11 |
| GHQ | Stain, Fetal Hemoglobin | 1 | 1 |
Review panels
- Hematology (12)
Most recent Caltag Laboratories, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K990641 | CALTAG FETAL HEMOGLOBIN TEST | GHQ | 1999-09-17 | 203 |
| K965232 | CALTAG CAL-LYSE | GKZ | 1997-05-14 | 134 |
| K964856 | CD3 FITC/CD19 R-PE/CD45 TRI-COLOR MONOCLONAL ANTIBODY COMBINATION | GKZ | 1997-01-17 | 44 |
| K963954 | CD 19 R-PE, CD19 TRI-COLOR MONOCLONAL ANTIBODY | GKZ | 1996-11-25 | 54 |
| K951073 | CD3 TRI-COLOR/CD4 R-PE/CD8 FITC MONOCLONAL ANTIBODY COMBINATION | GKZ | 1995-12-21 | 288 |
| K950918 | CD3 FITC/CD4 R-PE MONOCLONAL ANTIBODY COMBINATION | GKZ | 1995-12-21 | 295 |
| K950917 | CD3 FITC/CD8 R-PE/CD45 TRI-COLOR MONOCLONAL ANTIBODY COMBINATION | GKZ | 1995-12-21 | 295 |
| K950916 | CD3 FITC/CD8 R-PE MONOCLONAL ANTIBODY COMBINATION | GKZ | 1995-12-21 | 295 |
| K950919 | CD3 FITC/CD4 R-PE/CD45 TRI-COLOR MONOCLONAL ANTIBODY COMBINATION | GKZ | 1995-12-20 | 294 |
| K944128 | CALTAG CD4 R-PE MONOCLONAL ANTIBODY | GKZ | 1995-06-20 | 301 |
2 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Caltag Laboratories, Inc..
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.
- Caltag Medsystems, Ltd. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Caltag Laboratories, Inc.?
FDA lists 12 510(k) clearances under the applicant name “Caltag Laboratories, Inc.” (first 1995, latest 1999), across 2 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Caltag Laboratories, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Caltag Laboratories, Inc. is 294 days.
Which FDA product codes appear under Caltag Laboratories, Inc.?
The most frequent FDA product codes under this applicant name are GKZ (Counter, Differential Cell, 11); GHQ (Stain, Fetal Hemoglobin, 1).
Next steps
- See all 12 Caltag Laboratories, Inc. clearances with predicates and recalls
- Run predicate analysis for product code GKZ, Caltag Laboratories, Inc.'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.