TECHNICON BGII ANALYZER— 510(k) K780716

Name: FDA 510(k) clearance K780716
Creator: U.S. Food and Drug Administration
Published: 1978-06-14

Substantially Equivalent

Technicon Instruments Corp.

FDA 510(k) clearance K780716 for TECHNICON BGII ANALYZER, Substantially Equivalent on 1978-06-14. Applicant: Technicon Instruments Corp.. Device class: 2.

Clearance details

Applicant: Technicon Instruments Corp.
Product code: Code CHL
Device class: Class 2
Regulation: 21 CFR 862.1120
Advisory panel: Clinical Chemistry
Date received: 1978-04-27
Decision date: 1978-06-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code CHL

view all

K252207 — ABL90 FLEX PLUS System, safeCLINITUBES2026-04-10
K244014 — i-STAT CG4+ cartridge with the i-STAT 1 System2025-05-02
K240998 — ABL90 FLEX PLUS System2024-12-13
K230285 — i-STAT CG8+ cartridge with the i-STAT 1 System2023-10-27
K221900 — Stat Profile Prime Plus Analyzer System2023-09-29

More clearances from Technicon Instruments Corp.

view all

K914511 — TECHNICON AXON(TM) SYSTEM METHODS ANYALYE HDL CHOL1991-11-27
K914888 — TECHNICON CHEM 1(TM) SYST (GEN2 SYST)1991-11-27
K914025 — TECHNICON AXON(TM) SYSTEMS, ALT(P 5-P)/AST(P 5-P)1991-11-22
K912616 — TECHNICON IMMUNO 1 TM SYSTEM ADDITIONAL ANALYTES1991-09-25
K912413 — CHEM-LINK DATA BASE MANAGER1991-07-01

Adverse events under product code CHL

product code CHL

Death: 20
Malfunction: 999
Total: 1,019

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

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