FDA 510(k) Premarket Notification K081319: DIMENSION CLINICAL CHEMISTRY SYSTEM LIPASE CALIBRATOR, MODEL DC56

Submission Details & Decision

Normalized public record details for 510(k) notification K081319.

Source Dataset

FDA 510(k) Premarket Notifications

510(k) Number

K081319

Applicant / Sponsor

Siemens Healthcare Diagnostics, Inc.

Device Name

DIMENSION CLINICAL CHEMISTRY SYSTEM LIPASE CALIBRATOR, MODEL DC56

Product Code

JIT

Decision Date

2008-08-04

Decision / Status

Substantially Equivalent (SESE)

Advisory Committee

Clinical Chemistry (CH)

Clearance Type

Abbreviated

Third Party Flag

Date Received

2008-05-12

Related Establishments / Registrations

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SCIENTIFIC SUPPLIES & TECHNOLOGY, INC. Registration: 1036362 View Registration
MERCEDES MEDICAL LLC Registration: 1063851 View Registration
HEMAGEN DIAGNOSTICS, INC. Registration: 1181055 View Registration
Fisher Diagnostics Registration: 1181121 View Registration
WATERS CORPORATION Registration: 1218959 View Registration
NOVA BIOMEDICAL CORPORATION Registration: 1219029 View Registration
Siemens Healthcare Diagnostics Inc. Registration: 1219913 View Registration
MEDICA CORP. Registration: 1220972 View Registration
ALDEN MEDICAL LLC Registration: 1221361 View Registration
VERICHEM LABORATORIES, INC. Registration: 1221645 View Registration
CURRIER PLASTICS Registration: 1319436 View Registration
ORTHO-CLINICAL DIAGNOSTICS, INC. Registration: 1319681 View Registration
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HORIBA INSTRUMENTS INCORPORATED Registration: 1827821 View Registration
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INOVA DIAGNOSTICS, INC. Registration: 2026994 View Registration
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FUJIFILM Healthcare Manufacturing Corporation Minamiashigara Takematsu Office Registration: 2155 View Registration
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