The following data is part of a premarket notification filed by Hybritech, Inc. with the FDA for Icon Strep B Immunoenzymetric Assay.
| Device ID | K911417 |
| 510k Number | K911417 |
| Device Name: | ICON STREP B IMMUNOENZYMETRIC ASSAY |
| Classification | Antisera, All Groups, Streptococcus Spp. |
| Applicant | HYBRITECH, INC. 11095 TORREYANA RD. P.O. BOX 269006 San Diego, CA 92126 |
| Contact | Joanne Martinis |
| Correspondent | Joanne Martinis 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 | 1991-04-01 |
| Decision Date | 1991-07-24 |