CLINISTAT TRIGLYCERIDES REAGENT TEST— 510(k) K885134

Name: FDA 510(k) clearance K885134
Creator: U.S. Food and Drug Administration
Published: 1989-02-10

Substantially Equivalent

Heraeus Kulzer, Inc.

FDA 510(k) clearance K885134 for CLINISTAT TRIGLYCERIDES REAGENT TEST, Substantially Equivalent on 1989-02-10. Applicant: Heraeus Kulzer, Inc.. Device class: 1.

Clearance details

Applicant: Heraeus Kulzer, Inc.
Product code: Code JGY
Device class: Class 1
Regulation: 21 CFR 862.1705
Advisory panel: Clinical Chemistry
Date received: 1988-12-12
Decision date: 1989-02-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Elkhart, IN, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code JGY

view all

K120664 — PICCOLO TRGLYCERIDES-CAPILLARY TEST SYSTEM2012-04-24
K023639 — PICCOLO TRIGLYCERIDES TEST SYSTEM2003-01-24
K000586 — BIOSCANNER TRIGLYCERIDES TEST STRIPS2000-07-03
K991894 — BIOSCANNER TRIGLYCERIDES TEST STRIPS2000-05-24
K971005 — TRIGLYCERIDES1997-04-21

More clearances from Heraeus Kulzer, Inc.

view all

Data sourced from openFDA. This site is unofficial and independent of the FDA.