The following data is part of a premarket notification filed by Immuno Diagnostic Center, Inc. with the FDA for Myoglobin Elisa Test Kit.
| Device ID | K923195 |
| 510k Number | K923195 |
| Device Name: | MYOGLOBIN ELISA TEST KIT |
| Classification | Myoglobin, Antigen, Antiserum, Control |
| Applicant | IMMUNO DIAGNOSTIC CENTER, INC. 9978 MONROE DR., SUITE 303 Dallas, TX 75220 |
| Contact | Amal Mukherjee |
| Correspondent | Amal Mukherjee IMMUNO DIAGNOSTIC CENTER, INC. 9978 MONROE DR., SUITE 303 Dallas, TX 75220 |
| Product Code | DDR |
| CFR Regulation Number | 866.5680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-06-30 |
| Decision Date | 1992-11-06 |