The following data is part of a premarket notification filed by Mallinckrodt Critical Care with the FDA for Chloride Test Kit.
Device ID | K842011 |
510k Number | K842011 |
Device Name: | CHLORIDE TEST KIT |
Classification | Mercuric Thiocyanate, Colorimetry, Chloride |
Applicant | MALLINCKRODT CRITICAL CARE 4221 Richmond Rd., N.W. Walker, MI 49534 |
Product Code | CHJ |
CFR Regulation Number | 862.1170 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1984-05-17 |
Decision Date | 1984-06-22 |