EMIT(R) II CALIBRATOR LEVEL 0 (NEGATIVE)

Calibrators, Drug Mixture

SYVA CO.

The following data is part of a premarket notification filed by Syva Co. with the FDA for Emit(r) Ii Calibrator Level 0 (negative).

Pre-market Notification Details

• Device ID: K902581
• 510k Number: K902581
• Device Name: EMIT(R) II CALIBRATOR LEVEL 0 (NEGATIVE)
• Classification: Calibrators, Drug Mixture
• Applicant: SYVA CO. 900 ARASTRADERO RD. P.O. BOX 10058 Palo Alto, CA 94303
• Contact: Rogers, Jr.
• Correspondent: Rogers, Jr.; SYVA CO. 900 ARASTRADERO RD. P.O. BOX 10058 Palo Alto, CA 94303
• Product Code: DKB
• CFR Regulation Number: 862.3200 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1990-06-11
• Decision Date: 1990-07-27

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00842768001703	K902581	000