The following data is part of a premarket notification filed by Analytical Products, Inc. with the FDA for Api Uniscept Plus Autoinoculator.
Device ID | K831341 |
510k Number | K831341 |
Device Name: | API UNISCEPT PLUS AUTOINOCULATOR |
Classification | Device, Microtiter Diluting/dispensing |
Applicant | ANALYTICAL PRODUCTS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | JTC |
CFR Regulation Number | 866.2500 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1983-04-25 |
Decision Date | 1983-06-02 |