The following data is part of a premarket notification filed by Hml Inc/biotechnology Transfer with the FDA for Chemistry Analyzer, Gen. Purpose.
Device ID | K842311 |
510k Number | K842311 |
Device Name: | CHEMISTRY ANALYZER, GEN. PURPOSE |
Classification | Colorimeter, Photometer, Spectrophotometer For Clinical Use |
Applicant | HML INC/BIOTECHNOLOGY TRANSFER 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | JJQ |
CFR Regulation Number | 862.2300 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1984-06-12 |
Decision Date | 1984-07-25 |