The following data is part of a premarket notification filed by Mercedes Scientific Co., Inc. with the FDA for Quik-dip Blood Stain.
Device ID | K830127 |
510k Number | K830127 |
Device Name: | QUIK-DIP BLOOD STAIN |
Classification | Wright's Stain |
Applicant | MERCEDES SCIENTIFIC CO., INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | IAF |
CFR Regulation Number | 864.1850 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1983-01-12 |
Decision Date | 1983-02-15 |