FDA 510(k) Premarket Notification K982637: IMMULITE PSA CONTROL MODULE, MODEL LPSCM

Submission Details & Decision

Normalized public record details for 510(k) notification K982637.

Source Dataset

FDA 510(k) Premarket Notifications

510(k) Number

K982637

Applicant / Sponsor

Diagnostic Products Corp.

Device Name

IMMULITE PSA CONTROL MODULE, MODEL LPSCM

Product Code

JJY

Decision Date

1998-08-12

Decision / Status

Substantially Equivalent (SESE)

Advisory Committee

Clinical Chemistry (CH)

Clearance Type

Special

Third Party Flag

Date Received

1998-07-29

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