The following data is part of a premarket notification filed by Immuno Nuclear Corp. with the FDA for Biotech's Ige Immuno Response Test Isotope Unit.
| Device ID | K863743 |
| 510k Number | K863743 |
| Device Name: | BIOTECH'S IGE IMMUNO RESPONSE TEST ISOTOPE UNIT |
| Classification | System, Test, Radioallergosorbent (rast) Immunological |
| Applicant | IMMUNO NUCLEAR CORP. 1951 NORTHWESTERN AVE. P.O. BO 285 Stillwater, MN 55082 |
| Contact | Lisa J Andersen |
| Correspondent | Lisa J Andersen IMMUNO NUCLEAR CORP. 1951 NORTHWESTERN AVE. P.O. BO 285 Stillwater, MN 55082 |
| Product Code | DHB |
| CFR Regulation Number | 866.5750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-09-24 |
| Decision Date | 1986-12-15 |