Consolidated Technologies, Inc.: FDA clearances and approvals
Consolidated Technologies, Inc. has 20 FDA 510(k) clearances (first 1991, latest 2000), across 12 product codes in 5 review panels. Median 510(k) review time: 34 days.
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 |
|---|---|---|---|
| JJY | Multi-Analyte Controls, All Kinds (Assayed) | 7 | 7 |
| JJW | Urinalysis Controls (Assayed And Unassayed) | 2 | 2 |
| LAS | Drug Specific Control Materials | 2 | 2 |
| DCK | C-Reactive Protein, Antigen, Antiserum, And Control | 1 | 1 |
| DGR | Whole Human Serum, Antigen, Antiserum, Control | 1 | 1 |
| DHR | System, Test, Rheumatoid Factor | 1 | 1 |
| DIF | Drug Mixture Control Materials | 1 | 1 |
| DKB | Calibrators, Drug Mixture | 1 | 1 |
| GMP | Antisera, Control For Nontreponemal Tests | 1 | 1 |
| KTN | System, Test, Infectious Mononucleosis | 1 | 1 |
Plus 2 more product codes.
Review panels
- Clinical Chemistry (9)
- Clinical Toxicology (4)
- Immunology (3)
- Microbiology (3)
- Hematology (1)
Most recent Consolidated Technologies, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K000116 | QUALITROL URINALYSIS WITH MICROSCOPICS CONTROL, LEVELS 1,2 AND 3 | JJY | 2000-02-15 | 32 |
| K992578 | URINE CHEMISTRY CONTROL, LEVEL 2 | JJW | 1999-09-03 | 32 |
| K992576 | URINE CHEMISTRY CONTROL, LEVEL 1 | JJW | 1999-09-03 | 32 |
| K992151 | REFERENCE MATERIAL FOR DELTA-9-THC-COOH IN HUMAN URINE | LAS | 1999-07-14 | 20 |
| K981339 | QUICKCHECK LYOPHILIZED CHEMISTRY CONTROL CONFORMANCE CHEMISTRY CONTROL C3 | JJY | 1998-04-21 | 8 |
| K974699 | REFERENCE MATERIAL FOR AMPHETAMINE/METHAMPHETAMINE IN HUMAN URINE | DKB | 1998-01-22 | 37 |
| K973469 | QUIKCHECK UNASSAYED CHEMISTRY CONTROL LEVELS 1 AND 2, CONFORMANCEMCCLIQUICHEM UNASSAYED LIQUID CHEMISTRY CONTROL LEVELS | JJY | 1997-09-25 | 21 |
| K972146 | QUALITROL UNASSAYED H. PYLORI CONTROL SET POSITIVE AND NEGATIVE CONTROLS | LYR | 1997-07-08 | 29 |
| K972080 | QUALITROL DHP IMMUNOASSAY CONTROL LEVELS 1,2 AND 3, CONFORMANCEE MCC-LIGAND CONTROL LEVELS 1, 2 AND 3 | JJY | 1997-06-18 | 15 |
| K961815 | QUALITROL ANA CONTROL SERUM SET | LKJ | 1996-09-27 | 140 |
10 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Consolidated Technologies, Inc..
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Consolidated Technologies, Inc. have?
Consolidated Technologies, Inc. has 20 FDA 510(k) clearances (first 1991, latest 2000), across 12 product codes in 5 review panels.
How long does FDA take to clear Consolidated Technologies, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Consolidated Technologies, Inc.'s cleared 510(k)s is 34 days.
What devices does Consolidated Technologies, Inc. make?
Its most frequent FDA product codes are JJY (Multi-Analyte Controls, All Kinds (Assayed), 7); JJW (Urinalysis Controls (Assayed And Unassayed), 2); LAS (Drug Specific Control Materials, 2).
Has Consolidated Technologies, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Consolidated Technologies, Inc. Related entities may recall under other names.
Next steps
- See all 20 Consolidated Technologies, Inc. clearances with predicates and recalls
- Run predicate analysis for product code JJY, Consolidated Technologies, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.