The following data is part of a premarket notification filed by Marion Laboratories, Inc. with the FDA for Multi-gram Developing Tank R-12 & R-3.
Device ID | K812919 |
510k Number | K812919 |
Device Name: | MULTI-GRAM DEVELOPING TANK R-12 & R-3 |
Classification | Tanks, Developing, Tlc |
Applicant | MARION LABORATORIES, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | DKK |
CFR Regulation Number | 862.2270 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1981-10-19 |
Decision Date | 1981-11-02 |