The following data is part of a premarket notification filed by Electro-nucleonics Laboratories, Inc. with the FDA for Amylase Lts.
Device ID | K862640 |
510k Number | K862640 |
Device Name: | AMYLASE LTS |
Classification | Amyloclastic, Amylase |
Applicant | ELECTRO-NUCLEONICS LABORATORIES, INC. 7101 RIVERWOOD DR. Columbia, MD 21046 |
Contact | Labrec, Ph.d. |
Correspondent | Labrec, Ph.d. ELECTRO-NUCLEONICS LABORATORIES, INC. 7101 RIVERWOOD DR. Columbia, MD 21046 |
Product Code | CJA |
CFR Regulation Number | 862.1070 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1986-07-10 |
Decision Date | 1986-09-09 |