FDA 510(k) Premarket Notification K851403: VENTREZYME ALLERGEN DATA REDUCTION SYSTEM

Submission Details & Decision

Normalized public record details for 510(k) notification K851403.

Source Dataset

FDA 510(k) Premarket Notifications

510(k) Number

K851403

Applicant / Sponsor

Ventrex Laboratories, Inc.

Device Name

VENTREZYME ALLERGEN DATA REDUCTION SYSTEM

Product Code

JQW

Decision Date

1985-06-21

Decision / Status

Substantially Equivalent (SESE)

Advisory Committee

Clinical Chemistry (CH)

Clearance Type

Traditional

Third Party Flag

Date Received

1985-04-09

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