FDA 510(k) Premarket Notification K021022: HEMOSIL LOW ABNORMAL CONTROLLED (ASSAYED); HEMOSIL LOW ABNORMAL CONTROL 2 (UNASSAYED)

Submission Details & Decision

Normalized public record details for 510(k) notification K021022.

Source Dataset

FDA 510(k) Premarket Notifications

510(k) Number

K021022

Applicant / Sponsor

Instrumentation Laboratory CO

Device Name

HEMOSIL LOW ABNORMAL CONTROLLED (ASSAYED); HEMOSIL LOW ABNORMAL CONTROL 2 (UNASSAYED)

Product Code

GGN

Decision Date

2002-05-14

Decision / Status

Substantially Equivalent (SESE)

Advisory Committee

Hematology (HE)

Clearance Type

Traditional

Third Party Flag

Date Received

2002-03-29

Related Establishments / Registrations

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