The following data is part of a premarket notification filed by Marion Laboratories, Inc. with the FDA for Culturette Brand Pva.
Device ID | K790815 |
510k Number | K790815 |
Device Name: | CULTURETTE BRAND PVA |
Classification | Solution, Carnoy's |
Applicant | MARION LABORATORIES, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | IGM |
CFR Regulation Number | 864.4010 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1979-04-27 |
Decision Date | 1979-05-15 |