AUTOBEAD THYROID UPTAKE— 510(k) K930689

Clearance details

Applicant

Bio-Chem Laboratory Systems, Inc.

Product code

Code KHO

Device class

Class 1

Regulation

21 CFR 862.2560

Advisory panel

Clinical Chemistry

Date received

1993-02-10

Decision date

1993-11-10

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Lakewood, NJ, 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

• K945271 — ATAC 8000 RANDOM ACCESS CHEMISTRY SYSTEM1995-04-20
• K930006 — AUTOBEAD TSH ENZYME IMMUNOASSAY REAGENT KIT1993-09-09
• K926563 — AUTOBEAD(TM) T4 ENZYME IMMUNOASSAY TEST KIT1993-03-18
• K924084 — ATAC 6000 CHEMISTRY ANALYZER1992-09-29

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 →