COROMETRICS MEDICAL SYST. 220 PH ANALY.— 510(k) K812552

Name: FDA 510(k) clearance K812552
Creator: U.S. Food and Drug Administration
Published: 1981-09-23

Substantially Equivalent

Transidyne General Corp.

FDA 510(k) clearance K812552 for COROMETRICS MEDICAL SYST. 220 PH ANALY., Substantially Equivalent on 1981-09-23. Applicant: Transidyne General Corp.. Device class: 2.

Clearance details

Applicant: Transidyne General Corp.
Product code: Code CHL
Device class: Class 2
Regulation: 21 CFR 862.1120
Advisory panel: Clinical Chemistry
Date received: 1981-09-04
Decision date: 1981-09-23
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 Transidyne General Corp.

view all

K961217 — BODILY FLUID DISPOSAL KIT1996-07-25
K955658 — LACERATION TRAY1996-01-25
K950743 — ORAL PROCEDURE PACK1995-03-31
K950773 — PROPHYLAXIS PACK1995-03-31
K950449 — SURGICAL BUR1995-03-01

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.