The following data is part of a premarket notification filed by Precision Technology, Inc. with the FDA for Acculab Supplies Chemical Analyzers.
Device ID | K840501 |
510k Number | K840501 |
Device Name: | ACCULAB SUPPLIES CHEMICAL ANALYZERS |
Classification | Analyzer, Chemistry (photometric, Discrete), For Clinical Use |
Applicant | PRECISION TECHNOLOGY, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | JJE |
CFR Regulation Number | 862.2160 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1984-02-06 |
Decision Date | 1984-04-04 |