GLUCOSE (HEXOKINASE) LIQUID REAGENT, MODEL G518-150— 510(k) K000102

Clearance details

Applicant

Teco Diagnostics

Product code

Code CFR

Device class

Class 2

Regulation

21 CFR 862.1345

Advisory panel

Clinical Chemistry

Date received

2000-01-13

Decision date

2000-02-08

Decision

Substantially Equivalent

Clearance type

Special

Location

Anaheim, CA, US

• K253490 — Glucose HK Gen.3; ONLINE DAT Methadone II; cobas pro integrated solutions2026-02-12
• K252357 — Glucose22025-10-24
• K220134 — cobas pure integrated solutions, Glucose HK Gen.3, ISE indirect Na for Gen.2, ONLINE DAT Methadone II, Elecsys TSH2022-09-16
• K191899 — Glucose HK Gen.3, ISE indirect Na for Gen.2, Elecsys TSH, cobas pro integrated solutions2019-08-16
• K170316 — ALINITY C GLUCOSE REAGENT KIT, ALINITY C SYSTEM2017-10-19

• K170118 — Scanostics UTI Check Application Test System2017-09-21
• K141289 — TC-THUNDERBOLT AUTOMATED URINE ANALYZER SYSTEM AND TC-THUNDERBOLT URS-10 STRIPS2015-07-24
• K131600 — URS-2GP (GLUCOSE PROTEIN) URINE STRIPS2014-05-29
• K111206 — TECO DIAGNOSTICS SALIVA ALCOHOL TEST2011-10-04
• K100024 — TECO DIAGNOSTICS UTI DETECTION STRIPS2011-02-17