The following data is part of a premarket notification filed by Analytical Products, Inc. with the FDA for Api Uniscept Plus 140 Inoculator.
Device ID | K831462 |
510k Number | K831462 |
Device Name: | API UNISCEPT PLUS 140 INOCULATOR |
Classification | Device, Microtiter Diluting/dispensing |
Applicant | ANALYTICAL PRODUCTS, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
Product Code | JTC |
CFR Regulation Number | 866.2500 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1983-05-06 |
Decision Date | 1983-08-12 |