The following data is part of a premarket notification filed by Electro-nucleonics, Inc. with the FDA for Deltatest (r) Lipase Ii.
Device ID | K893718 |
510k Number | K893718 |
Device Name: | DELTATEST (R) LIPASE II |
Classification | Olive Oil Emulsion (turbidimetric), Lipase |
Applicant | ELECTRO-NUCLEONICS, INC. 8310 GUILFORD RD. Columbia, MD 21046 |
Contact | Karen H Darcy |
Correspondent | Karen H Darcy ELECTRO-NUCLEONICS, INC. 8310 GUILFORD RD. Columbia, MD 21046 |
Product Code | CET |
CFR Regulation Number | 862.1465 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1989-05-17 |
Decision Date | 1989-09-28 |