The following data is part of a premarket notification filed by Incstar Corp. with the FDA for Rrt Total Ige Test Kit.
| Device ID | K874541 |
| 510k Number | K874541 |
| Device Name: | RRT TOTAL IGE TEST KIT |
| Classification | Ige, Antigen, Antiserum, Control |
| Applicant | INCSTAR CORP. 1990 INSUSTRIAL BLVD. P.O. BOX 285 Stillwater, MN 55082 -0285 |
| Contact | Lisa J Stone |
| Correspondent | Lisa J Stone INCSTAR CORP. 1990 INSUSTRIAL BLVD. P.O. BOX 285 Stillwater, MN 55082 -0285 |
| Product Code | DGC |
| CFR Regulation Number | 866.5510 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-11-03 |
| Decision Date | 1988-02-17 |