FDA 510(k) Premarket Notification K060322: CLINIQA DRY QC CHEMISTRY CONTROL, LEVELS 1 AND 2, ASSAYED, CLINIQA DRY QC CHEMISTRY CONTROL, LEVEL 1 AND 2 UNASSAYED

Submission Details & Decision

Normalized public record details for 510(k) notification K060322.

Source Dataset

FDA 510(k) Premarket Notifications

510(k) Number

K060322

Applicant / Sponsor

Cliniqa Corporation

Device Name

CLINIQA DRY QC CHEMISTRY CONTROL, LEVELS 1 AND 2, ASSAYED, CLINIQA DRY QC CHEMISTRY CONTROL, LEVEL 1 AND 2 UNASSAYED

Product Code

JIT

Decision Date

2006-03-21

Decision / Status

Substantially Equivalent (SESE)

Advisory Committee

Clinical Chemistry (CH)

Clearance Type

Traditional

Third Party Flag

Date Received

2006-02-09

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