# Teco Diagnostics

- Location (FDA's records): Anaheim, CA
- FDA decisions: 55 (1993–2017): 55 510(k) clearances
- Names in FDA's records: Teco Diagnostics (51); Teco Diagnostics, Inc. (4)
- Product codes: JIL (8), JHI (4), JFJ (2), JIR (2), LCP (2), JMT (2), KQO (2), JFY (2), CDQ (2), KHS (2), KWW (1), JIO (1)
- Predicates its devices cite: 15 (4 its own); citations of its devices by later devices: 8 (4 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Tech-Co, Inc.: 3 (https://510kreport.com/company/tech)
- Siemens Healthcare Diagnostics, Inc.: 2 (https://510kreport.com/company/siemens-healthcare-diagnostics)
- ACON Laboratories, Inc.: 1 (https://510kreport.com/company/acon-laboratories)
- Heraeus Kulzer, Inc.: 1 (https://510kreport.com/company/heraeus-kulzer)
- Stanbio Laboratory: 1 (https://510kreport.com/company/stanbio-laboratory)
- Pointe Scientific, Inc.,: 1 (https://510kreport.com/company/pointe-scientific)
- Bd Vacutainer Systems Preanalyical Solutions: 1 (https://510kreport.com/company/bd-vacutainer-systems-preanalyical-solutions)
- Bayer Healthcare, LLC: 1 (https://510kreport.com/company/bayer-healthcare)

## Firms that cite its devices most
- Healgen Scientific,, LLC: 1 (https://510kreport.com/company/healgen-scientific)
- Chemtron Biotech, Inc.: 1 (https://510kreport.com/company/chemtron-biotech)
- Polymed Therapeutics, Inc.: 1 (https://510kreport.com/company/polymed-therapeutics)
- Randox Laboratories, Ltd.: 1 (https://510kreport.com/company/randox-laboratories)

## Its most-cited devices
- K964461: One -Step Urine/Serum Combo Pregnancy Card Test (1997), cited by 2
- K100024: Teco Diagnostics Uti Detection Strips (2011), cited by 1
- K981106: Urea Nitrogen (Bun) Liquid Reagent (1998), cited by 1
- K940469: Urine Reagent Strip-3 Parameters (1994), cited by 1
- K051526: Uritek-720+ Urine Analyzer (2005), cited by 1
- K050823: Direct HDL Cholesterol and Direct HDL/LDL Calibrator (2005), cited by 1

## Recent decisions
- K170118: Scanostics UTI Check Application Test System (Sep 21, 2017)
- K161527: Teco Creatinine Enzymatic Reagent Kit (Jul 21, 2017)
- K170200: Carbon Dioxide Reagent Set (Jun 1, 2017)
- K160372: Uritek TC-201 Urine Chemistry Test System (Jul 22, 2016)
- K152835: Uritek TC-201 Urine Chemistry Test System (Mar 7, 2016)
- K141289: TC-Thunderbolt Automated Urine Analyzer System and TC-Thunderbolt Urs-10 Strips (Jul 24, 2015)
- K131600: Urs-2GP (Glucose Protein) Urine Strips (May 29, 2014)
- K111206: Teco Diagnostics Saliva Alcohol Test (Oct 4, 2011)

Source page: https://510kreport.com/company/teco-diagnostics