Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

510(k) Premarket Notification
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
Device Classification Name enzyme immunoassay, phenobarbital
510(k) Number K874625
Device Name EMIT CONVENIENCE PACK: PHENOBARBITAL ASSAY
Applicant
SYVA CO.
900 ARASTRADERO RD.
P.O. BOX 10058
PALO ALTO,  CA  94303
Applicant Contact ELEANOR V CHIU
Correspondent
SYVA CO.
900 ARASTRADERO RD.
P.O. BOX 10058
PALO ALTO,  CA  94303
Correspondent Contact ELEANOR V CHIU
Regulation Number862.3660
Classification Product Code
DLZ  
Date Received11/10/1987
Decision Date 12/22/1987
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Toxicology
510k Review Panel Toxicology
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-