The following data is part of a premarket notification filed by Diagnostic Products Corp. with the FDA for Immulite Cannabinoids.
Device ID | K963916 |
510k Number | K963916 |
Device Name: | IMMULITE CANNABINOIDS |
Classification | Enzyme Immunoassay, Cannabinoids |
Applicant | DIAGNOSTIC PRODUCTS CORP. 5700 WEST 96TH ST. Los Angeles, CA 90045 -5597 |
Contact | Edward M Levine, Ph.d. |
Correspondent | Edward M Levine, Ph.d. DIAGNOSTIC PRODUCTS CORP. 5700 WEST 96TH ST. Los Angeles, CA 90045 -5597 |
Product Code | LDJ |
CFR Regulation Number | 862.3870 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1996-09-30 |
Decision Date | 1997-04-28 |
Summary: | summary |