FDA 510(k) Premarket Notification K842244: LACTATE DENYDRO GENASE ASSAY KIT

Submission Details & Decision

Normalized public record details for 510(k) notification K842244.

Source Dataset

FDA 510(k) Premarket Notifications

510(k) Number

K842244

Applicant / Sponsor

Diagnostic Chemicals, Ltd. (Usa)

Device Name

LACTATE DENYDRO GENASE ASSAY KIT

Product Code

CFJ

Decision Date

1984-07-18

Decision / Status

Substantially Equivalent (SESE)

Advisory Committee

Clinical Chemistry (CH)

Clearance Type

Traditional

Third Party Flag

Date Received

1984-06-05

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