Technicon Instruments Corp.: FDA filings under this applicant name
FDA lists 157 510(k) clearances under the applicant name “Technicon Instruments Corp.” (first 1976, latest 1991), across 88 product codes in 8 review panels. Median 510(k) review time under this name: 39 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
Caduvo groups this applicant name under Siemens Healthineers, based on public ownership records.
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 |
|---|---|---|---|
| JJC | Analyzer, Chemistry (Sequential Multiple, Continuous Flow) Clinical Use | 12 | 12 |
| GKL | Counter, Cell, Automated (Particle Counter) | 8 | 8 |
| GKZ | Counter, Differential Cell | 6 | 6 |
| JGJ | Photometric Method, Magnesium | 6 | 6 |
| CKA | Nadh Oxidation/Nad Reduction, Alt/Sgpt | 4 | 4 |
| JGS | Electrode, Ion Specific, Sodium | 4 | 4 |
| KLI | Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine | 4 | 4 |
| CHJ | Mercuric Thiocyanate, Colorimetry, Chloride | 3 | 3 |
| CIC | Cresolphthalein Complexone, Calcium | 3 | 3 |
| CIX | Bromcresol Green Dye-Binding, Albumin | 3 | 3 |
Plus 78 more product codes.
Review panels
- Clinical Chemistry (96)
- Hematology (21)
- Immunology (18)
- Clinical Toxicology (13)
- Pathology (4)
- Ear, Nose and Throat (1)
- General Hospital (1)
- Microbiology (1)
Most recent Technicon Instruments Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K914888 | TECHNICON CHEM 1(TM) SYST (GEN2 SYST) | CIX | 1991-11-27 | 28 |
| K914511 | TECHNICON AXON(TM) SYSTEM METHODS ANYALYE HDL CHOL | LBS | 1991-11-27 | 49 |
| K914025 | TECHNICON AXON(TM) SYSTEMS, ALT(P 5-P)/AST(P 5-P) | CIT | 1991-11-22 | 74 |
| K912616 | TECHNICON IMMUNO 1 TM SYSTEM ADDITIONAL ANALYTES | KLI | 1991-09-25 | 104 |
| K912413 | CHEM-LINK DATA BASE MANAGER | JJQ | 1991-07-01 | 31 |
| K903825 | DRUG OF ABUSE ANALYSIS SYSTEM | DIS | 1990-09-27 | 38 |
| K903824 | DRUG OF ABUSE ANALYSIS SYSTEM FREE RADICAL ASSAY | DKZ | 1990-09-27 | 38 |
| K903305 | TECHNICON CHEM I SYSTEM CARBON DIOXIDE METHOD | KHS | 1990-09-27 | 65 |
| K903306 | TECHNICON CHEM I SYSTEM MAGNESIUM METHOD | JGJ | 1990-08-29 | 36 |
| K901410 | TECHNICON RA-2000(TM) SYSTEM | JJC | 1990-07-17 | 113 |
147 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Technicon Instruments 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.
Related HCPCS codes
HCPCS Level II codes whose descriptors match the device names of the product codes filed under Technicon Instruments Corp. (a text match, not an official crosswalk):
- J1460 — Injection, gamma globulin, intramuscular, 1 cc (via DAH)
- J1560 — Injection, gamma globulin, intramuscular, over 10 cc (via DAH)
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.
- Technicon Corp. (2 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Technicon Instruments Corp.?
FDA lists 157 510(k) clearances under the applicant name “Technicon Instruments Corp.” (first 1976, latest 1991), across 88 product codes in 8 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 Technicon Instruments Corp.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Technicon Instruments Corp. is 39 days.
Which FDA product codes appear under Technicon Instruments Corp.?
The most frequent FDA product codes under this applicant name are JJC (Analyzer, Chemistry (Sequential Multiple, Continuous Flow) Clinical Use, 12); GKL (Counter, Cell, Automated (Particle Counter), 8); GKZ (Counter, Differential Cell, 6).
Next steps
- See all 157 Technicon Instruments Corp. clearances with predicates and recalls
- Run predicate analysis for product code JJC, Technicon Instruments 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.