FDA 510(k) Premarket Notification K840557: REAGENTS & STANDARDS IL 501 NA/K

Submission Details & Decision

Normalized public record details for 510(k) notification K840557.

Source Dataset

FDA 510(k) Premarket Notifications

510(k) Number

K840557

Applicant / Sponsor

Shaban Mfg. Co.

Device Name

REAGENTS & STANDARDS IL 501 NA/K

Product Code

JGS

Decision Date

1984-04-04

Decision / Status

Substantially Equivalent (SESE)

Advisory Committee

Clinical Chemistry (CH)

Clearance Type

Traditional

Third Party Flag

Date Received

1984-02-08

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