EMIT CALIBRATER/CONTROL LEVEL 0, LEVEL 1, LEVEL 2, LEVEL 3, LEVEL 4, LEVEL 5

Calibrators, Drug Mixture

SYVA CO.

The following data is part of a premarket notification filed by Syva Co. with the FDA for Emit Calibrater/control Level 0, Level 1, Level 2, Level 3, Level 4, Level 5.

Pre-market Notification Details

• Device ID: K993755
• 510k Number: K993755
• Device Name: EMIT CALIBRATER/CONTROL LEVEL 0, LEVEL 1, LEVEL 2, LEVEL 3, LEVEL 4, LEVEL 5
• Classification: Calibrators, Drug Mixture
• Applicant: SYVA CO. 3403 YERBA BUENA RD. P.O. BOX 49013 San Jose, CA 95161 -9013
• Contact: Paul L Rogers
• Correspondent: Paul L Rogers; SYVA CO. 3403 YERBA BUENA RD. P.O. BOX 49013 San Jose, CA 95161 -9013
• Product Code: DKB
• CFR Regulation Number: 862.3200 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Abbreviated
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1999-11-05
• Decision Date: 1999-12-21
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00842768001789	K993755	000
00842768001772	K993755	000
00842768001765	K993755	000
00842768001758	K993755	000
00842768001741	K993755	000
00842768001734	K993755	000