The following data is part of a premarket notification filed by Hybritech, Inc. with the FDA for Tandem-e -ige Immunoezymetric Assay.
| Device ID | K823507 |
| 510k Number | K823507 |
| Device Name: | TANDEM-E -IGE IMMUNOEZYMETRIC ASSAY |
| Classification | Ige, Antigen, Antiserum, Control |
| Applicant | HYBRITECH, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | DGC |
| CFR Regulation Number | 866.5510 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-11-24 |
| Decision Date | 1982-12-28 |