FDA 510(k) Premarket Notification K821068: DSL 1020

Submission Details & Decision

Normalized public record details for 510(k) notification K821068.

Source Dataset

FDA 510(k) Premarket Notifications

510(k) Number

K821068

Applicant / Sponsor

Diagnostic Systems Laboratories, Inc.

Device Name

DSL 1020

Product Code

CGR

Decision Date

1982-05-05

Decision / Status

Substantially Equivalent (SESE)

Advisory Committee

Clinical Chemistry (CH)

Clearance Type

Traditional

Third Party Flag

Date Received

1982-04-16

Related Establishments / Registrations

SCIENTIFIC SUPPLIES & TECHNOLOGY, INC. Registration: 1036362 View Registration
ORTHO-CLINICAL DIAGNOSTICS, INC. Registration: 1319681 View Registration
MONOBIND, INC. Registration: 2020726 View Registration
BECKMAN COULTER, INC. Registration: 2122870 View Registration
DRG International, Inc. Registration: 2245285 View Registration
ORTHO-CLINICAL DIAGNOSTICS, INC. Registration: 2250051 View Registration
Ortho-Clinical Diagnostics European Support Center Registration: 3000308930 View Registration
Ortho Clinical Diagnostics Registration: 3002642396 View Registration
DRG INSTRUMENTS GMBH Registration: 3002800697 View Registration
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LIMITED Registration: 3002806944 View Registration
Diamond Diagnostics Inc. Registration: 3006198300 View Registration
Ortho-Clinical Diagnostics Registration: 3007111389 View Registration
EUROIMMUN US INC. Registration: 3007118747 View Registration
DIAFARMA ECZA DEPOSU VE MEDIKAL DIS TICARET DIS TIC LTD STI Registration: 3011989923 View Registration
Ortho Clinical Diagnostics, K.K. Registration: 3012963943 View Registration
IMMUNOCENTRIX CORPORATION Registration: 3022178699 View Registration
IMMUNODIAGNOSTIC SYSTEMS LTD. Registration: 8021924 View Registration
Beckman Coulter Mishima K.K. Registration: 9612296 View Registration

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