The following data is part of a premarket notification filed by Electrophoresis Corp. Of America with the FDA for Ponceau S Stain Set.
Device ID | K792550 |
510k Number | K792550 |
Device Name: | PONCEAU S STAIN SET |
Classification | Stains, Hematology |
Applicant | ELECTROPHORESIS CORP. OF AMERICA 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | KQC |
CFR Regulation Number | 864.1850 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1979-12-10 |
Decision Date | 1980-01-16 |