The following data is part of a premarket notification filed by Simmler, Inc. with the FDA for Multichem Calcium S0910.
Device ID | K873697 |
510k Number | K873697 |
Device Name: | MULTICHEM CALCIUM S0910 |
Classification | Cresolphthalein Complexone, Calcium |
Applicant | SIMMLER, INC. POST OFFICE BOX 25179 St. Louis, MO 63125 |
Contact | Crider, Phd |
Correspondent | Crider, Phd SIMMLER, INC. POST OFFICE BOX 25179 St. Louis, MO 63125 |
Product Code | CIC |
CFR Regulation Number | 862.1145 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-09-14 |
Decision Date | 1987-10-02 |