REVISED LABELING FOR SYVA BARBITURATE ASSAYS

Enzyme Immunoassay, Barbiturate

SYVA CO.

The following data is part of a premarket notification filed by Syva Co. with the FDA for Revised Labeling For Syva Barbiturate Assays.

Pre-market Notification Details

Device IDK874702
510k NumberK874702
Device Name:REVISED LABELING FOR SYVA BARBITURATE ASSAYS
ClassificationEnzyme Immunoassay, Barbiturate
Applicant SYVA CO. 900 ARASTRADERO RD. P.O. BOX 10058 Palo Alto,  CA  94303
ContactEleanor V Chiu
CorrespondentEleanor V Chiu
SYVA CO. 900 ARASTRADERO RD. P.O. BOX 10058 Palo Alto,  CA  94303
Product CodeDIS  
CFR Regulation Number862.3150 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1987-11-16
Decision Date1988-01-05

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00842768001604 K874702 000

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