The following data is part of a premarket notification filed by Quantimetrix Corp. with the FDA for Acetaminopher Assay Kit.
Device ID | K832045 |
510k Number | K832045 |
Device Name: | ACETAMINOPHER ASSAY KIT |
Classification | Colorimetry, Acetaminophen |
Applicant | QUANTIMETRIX CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | LDP |
CFR Regulation Number | 862.3030 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1983-06-24 |
Decision Date | 1983-10-04 |