MR7000 WITH TIME MANAGER SOFTWARE (TMS)— 510(k) K934111

Name: FDA 510(k) clearance K934111
Creator: U.S. Food and Drug Administration
Published: 1994-11-02

Substantially Equivalent

Dynatech Laboratories, Inc.

FDA 510(k) clearance K934111 for MR7000 WITH TIME MANAGER SOFTWARE (TMS), Substantially Equivalent on 1994-11-02. Applicant: Dynatech Laboratories, Inc.. Device class: 1.

Clearance details

Applicant: Dynatech Laboratories, Inc.
Product code: Code JQP
Device class: Class 1
Regulation: 21 CFR 862.2100
Advisory panel: Clinical Chemistry
Date received: 1993-08-03
Decision date: 1994-11-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Chantilly, VA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code JQP

view all

K113007 — BIONIME DIABETES MANAGEMENT SYSTEM VI.02012-02-27
K983468 — FASTTAKE ADAPTER, MODEL # P/N 020-072-011998-12-17
K964460 — THE ROBOLITE1997-01-24
K953652 — PRENVAL I1995-09-15
K923316 — EXPRESSO CARTRIDGE1993-02-23

More clearances from Dynatech Laboratories, Inc.

view all

K962265 — MLX MICROTITER PLATE LUMINOMETER1996-07-25
K943701 — MRX MICROPLATE READER1994-10-20
K923456 — MICROLITE MICROTITER PLATE LUMINOMETER ML30001992-10-13
K915896 — MICROLITE MICROTITER PLATE LUMINOMETER ML2250/MODI1992-05-04
K920888 — MICROLITE MICROTITER PLATE LUMINOMETER ML22001992-03-19

Adverse events under product code JQP

product code JQP

Death: 3
Malfunction: 690
Total: 693

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.