The following data is part of a premarket notification filed by Hybritech, Inc. with the FDA for Tandem Icon Strep A Immunoenzymetric Assay Kit.
| Device ID | K860778 |
| 510k Number | K860778 |
| Device Name: | TANDEM ICON STREP A IMMUNOENZYMETRIC ASSAY KIT |
| Classification | Antisera, All Groups, Streptococcus Spp. |
| Applicant | HYBRITECH, INC. 11095 TORREYANA RD. P.O. BOX 269006 San Diego, CA 92126 |
| Contact | Bruni, Ph.d. |
| Correspondent | Bruni, Ph.d. HYBRITECH, INC. 11095 TORREYANA RD. P.O. BOX 269006 San Diego, CA 92126 |
| Product Code | GTZ |
| CFR Regulation Number | 866.3740 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-03-03 |
| Decision Date | 1986-04-04 |