The following data is part of a premarket notification filed by Analytical Products, Inc. with the FDA for Api Anaident.
Device ID | K831032 |
510k Number | K831032 |
Device Name: | API ANAIDENT |
Classification | Kit, Anaerobic Identification |
Applicant | ANALYTICAL PRODUCTS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | JSP |
CFR Regulation Number | 866.2660 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1983-03-30 |
Decision Date | 1983-05-05 |