The following data is part of a premarket notification filed by Stanbio Laboratory with the FDA for Chloride Test Set, Cat.# 0210.
Device ID | K781635 |
510k Number | K781635 |
Device Name: | CHLORIDE TEST SET, CAT.# 0210 |
Classification | Mercuric Thiocyanate, Colorimetry, Chloride |
Applicant | STANBIO LABORATORY 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | CHJ |
CFR Regulation Number | 862.1170 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1978-09-22 |
Decision Date | 1978-10-03 |