FDA 510(k) Premarket Notification K973662: ACCU-CHEK(R)COMPLETE SYSTEM/METER & ACCU-CHEK ADVANTAGE TEST STRIPS/ACCU-CHEK ADVANTAGE H TEST STRIPS

Submission Details & Decision

Normalized public record details for 510(k) notification K973662.

Source Dataset

FDA 510(k) Premarket Notifications

510(k) Number

K973662

Applicant / Sponsor

Boehringer Mannheim Corp.

Device Name

ACCU-CHEK(R)COMPLETE SYSTEM/METER & ACCU-CHEK ADVANTAGE TEST STRIPS/ACCU-CHEK ADVANTAGE H TEST STRIPS

Product Code

LFR

Decision Date

1997-12-15

Decision / Status

Substantially Equivalent (SESE)

Advisory Committee

Clinical Chemistry (CH)

Clearance Type

Traditional

Third Party Flag

Date Received

1997-09-25

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