FDA 510(k) Premarket Notification K011166: MODIFICATION TO EMIT 2000 THEOPHYLLINE ASSAY, MODEL OSR 4P229

Submission Details & Decision

Normalized public record details for 510(k) notification K011166.

Source Dataset

FDA 510(k) Premarket Notifications

510(k) Number

K011166

Applicant / Sponsor

Syva Co., Dade Behring, Inc.

Device Name

MODIFICATION TO EMIT 2000 THEOPHYLLINE ASSAY, MODEL OSR 4P229

Product Code

KLS

Decision Date

2001-05-10

Decision / Status

Substantially Equivalent (SESE)

Advisory Committee

Clinical Toxicology (TX)

Clearance Type

Special

Third Party Flag

Date Received

2001-04-16

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