The following data is part of a premarket notification filed by Incstar Corp. with the FDA for Ige Immuno Response Test (irt) Calibrator Unit.
| Device ID | K873676 |
| 510k Number | K873676 |
| Device Name: | IGE IMMUNO RESPONSE TEST (IRT) CALIBRATOR UNIT |
| Classification | System, Test, Radioallergosorbent (rast) Immunological |
| 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 | DHB |
| CFR Regulation Number | 866.5750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-09-14 |
| Decision Date | 1987-10-07 |