Clin Tech Diagnostics Corp.
United StatesFDA applicant, unverified
- Devices
- 5
What Clin Tech Diagnostics Corp. makes
Clin Tech Diagnostics Corp. manufactures reagent test sets and control materials for rapid diagnostic testing, including the SALICYLATE STAT-PAK for salicylate level analysis, the GLYCO-SEP REAGENT TEST SET for glucose monitoring, and the ACETAMINOPHEN STAT-PAK REAGENT SET for acetaminophen detection. They also supply human glycosylated controls like the GLYCO-TROL and combined controls such as the ACETAMINOPHEN/SALICYLATE CONTROL for laboratory quality assurance.
Their products are regulated under FDA 510(k) clearance, with devices classified as Class I and Class II. The company’s offerings are listed in the FDA’s 510(k) premarket notification registry, and the manufacturer is based in the United States.
Catalogue
Salicylate Stat-Pak Ref K813185
Regimes: 510(k) Registry: 510(k)Glyco-Sep Reagent Test Set Ref K820076
Regimes: 510(k) Registry: 510(k)Glyco-Trol Human Glycosylated Hom. Cont. Ref K802432
Regimes: 510(k) Registry: 510(k)Acetaminophen Stat-Pak Reagent Set Ref K821969
Regimes: 510(k) Registry: 510(k)Acetaminophen/Salicylate Control Ref K810235
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Clin Tech Diagnostics Corp. have in the registry?
The registry currently lists 5 devices for Clin Tech Diagnostics Corp.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Clin Tech Diagnostics Corp.'s devices?
Among its 5 most recently registered devices, Clin Tech Diagnostics Corp. has devices listed in FDA 510(k) (5 devices).
What risk classes do Clin Tech Diagnostics Corp.'s devices fall under?
Among its 5 most recently registered devices, the classes recorded for Clin Tech Diagnostics Corp.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Clin Tech Diagnostics Corp. in the registry?
The most recently registered devices listed for Clin Tech Diagnostics Corp. include SALICYLATE STAT-PAK, GLYCO-SEP REAGENT TEST SET, GLYCO-TROL HUMAN GLYCOSYLATED HOM. CONT. and ACETAMINOPHEN STAT-PAK REAGENT SET.