DIMENSION VISTA INTEGRATED SYSTEM

Analyzer, Chemistry (photometric, Discrete), For Clinical Use

DADE BEHRING, INC.

The following data is part of a premarket notification filed by Dade Behring, Inc. with the FDA for Dimension Vista Integrated System.

Pre-market Notification Details

• Device ID: K051087
• 510k Number: K051087
• Device Name: DIMENSION VISTA INTEGRATED SYSTEM
• Classification: Analyzer, Chemistry (photometric, Discrete), For Clinical Use
• Applicant: DADE BEHRING, INC. P.O. BOX 6101 BLDG 500;M.S.514 Newark, DE 19714 -6101
• Contact: Lorraine H Piestrak
• Correspondent: Lorraine H Piestrak; DADE BEHRING, INC. P.O. BOX 6101 BLDG 500;M.S.514 Newark, DE 19714 -6101
• Product Code: JJE
• Subsequent Product Code: CDQ
• Subsequent Product Code: CEM
• Subsequent Product Code: CEP
• Subsequent Product Code: CFQ
• Subsequent Product Code: CFT
• Subsequent Product Code: CGJ
• Subsequent Product Code: CGZ
• Subsequent Product Code: CKA
• Subsequent Product Code: DLZ
• Subsequent Product Code: JGS
• Subsequent Product Code: JHY
• Subsequent Product Code: JIT
• Subsequent Product Code: JIX
• Subsequent Product Code: JJY
• CFR Regulation Number: 862.2160 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2005-04-28
• Decision Date: 2005-07-11
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00842768030413	K051087	000
00842768016295	K051087	000
00842768016288	K051087	000
00842768016271	K051087	000
00842768016264	K051087	000
00842768015656	K051087	000
00630414949581	K051087	000
00630414949536	K051087	000
00842768028915	K051087	000
00630414593517	K051087	000
00842768016332	K051087	000
00842768016349	K051087	000
00842768017919	K051087	000
00842768016257	K051087	000
00842768016240	K051087	000
00842768016233	K051087	000
00842768016226	K051087	000
00842768015601	K051087	000
00842768015397	K051087	000
00842768033117	K051087	000
00842768016356	K051087	000
00842768024719	K051087	000