The following data is part of a premarket notification filed by Analytical Products, Inc. with the FDA for Api Turbicity Standard.
Device ID | K810762 |
510k Number | K810762 |
Device Name: | API TURBICITY STANDARD |
Classification | Chromium-51, Blood Volume |
Applicant | ANALYTICAL PRODUCTS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | JKP |
CFR Regulation Number | 862.1130 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1981-03-23 |
Decision Date | 1981-04-03 |