EMIT 2000 TOBRAMYCIN ASSAY EMIT 2000 TOBRAMYCIN CALIBRATORS

Radioimmunoassay, Tobramycin

SYVA CO., DADE BEHRING, INC.

The following data is part of a premarket notification filed by Syva Co., Dade Behring, Inc. with the FDA for Emit 2000 Tobramycin Assay Emit 2000 Tobramycin Calibrators.

Pre-market Notification Details

• Device ID: K003341
• 510k Number: K003341
• Device Name: EMIT 2000 TOBRAMYCIN ASSAY EMIT 2000 TOBRAMYCIN CALIBRATORS
• Classification: Radioimmunoassay, Tobramycin
• Applicant: SYVA CO., DADE BEHRING, INC. P.O. BOX 49013 3403 YERBA BUENA ROAD San Jose, CA 95161 -9013
• Contact: Paul L Roger
• Correspondent: Paul L Roger; SYVA CO., DADE BEHRING, INC. P.O. BOX 49013 3403 YERBA BUENA ROAD San Jose, CA 95161 -9013
• Product Code: KLB
• Subsequent Product Code: DLJ
• Subsequent Product Code: LDO
• CFR Regulation Number: 862.3900 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2000-10-25
• Decision Date: 2001-01-22

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00630414561677	K003341	000
00842768023309	K003341	000
00842768001079	K003341	000
00842768001062	K003341	000