FLUOROMETER, GENERAL USE— 510(k) K830624

Clearance details

Applicant

Abbott Diagnostics

Product code

Code KHO

Device class

Class 1

Regulation

21 CFR 862.2560

Advisory panel

Clinical Chemistry

Date received

1983-02-28

Decision date

1983-04-05

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Mountain View, CA, US

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• K973547 — TRIAGE STATMETER1998-01-13
• K971103 — AIA NEXIA-AUTOMATED ENZYME IMMUNOASSAY SYSTEM1997-06-27
• K962919 — VITROS IMMUNODIAGNOSTIC SYSTEM1996-10-18
• K952719 — BIOCIRCUITS IOS (IN-OFFICE SYSTEM)1995-11-22

• K964185 — IMX CA 1251997-11-04
• K972182 — ABBOTT STREP A CONTROLS1997-08-13
• K961439 — ABBOTT CELL-DYN 4000 SYSTEM1996-10-18
• K890491 — CELL-DYN 3000 MULTI-PARAMETER HEMATOLOGY ANALYER1989-04-18
• K881242 — CELL-DYN RAPID-LYSE AND HEMOGLOBLIN1988-04-21

Malfunction

1,339

Total

1,339

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 →