The following data is part of a premarket notification filed by Gull Laboratories, Inc. with the FDA for Cmv Igm Test.
| Device ID | K831711 |
| 510k Number | K831711 |
| Device Name: | CMV IGM TEST |
| Classification | Antibody Igm,if, Cytomegalovirus Virus |
| Applicant | GULL LABORATORIES, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | LKQ |
| CFR Regulation Number | 866.3175 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-05-27 |
| Decision Date | 1983-10-27 |