The following data is part of a premarket notification filed by Syva Co. with the FDA for Emit Ancillary Reagents.
Device ID | K844947 |
510k Number | K844947 |
Device Name: | EMIT ANCILLARY REAGENTS |
Classification | Apparatus, High Pressure Liquid Chromatography |
Applicant | SYVA CO. 900 ARASTRADERO RD. P.O. BOX 10058 Palo Alto, CA 94303 |
Contact | Joan Kurjian |
Correspondent | Joan Kurjian SYVA CO. 900 ARASTRADERO RD. P.O. BOX 10058 Palo Alto, CA 94303 |
Product Code | KIE |
CFR Regulation Number | 862.2260 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1984-12-20 |
Decision Date | 1985-06-28 |