The following data is part of a premarket notification filed by General Diagnostics with the FDA for Quali. Enzyme Immuno. Of Barbiturates In Urine.
Device ID | K864993 |
510k Number | K864993 |
Device Name: | QUALI. ENZYME IMMUNO. OF BARBITURATES IN URINE |
Classification | Enzyme Immunoassay, Barbiturate |
Applicant | GENERAL DIAGNOSTICS 160 COMMUNITY DR. Great Neck, NY 11021 |
Contact | Susan M Durham |
Correspondent | Susan M Durham GENERAL DIAGNOSTICS 160 COMMUNITY DR. Great Neck, NY 11021 |
Product Code | DIS |
CFR Regulation Number | 862.3150 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1986-12-22 |
Decision Date | 1987-03-31 |