The following data is part of a premarket notification filed by Hybritech, Inc. with the FDA for Tandem-m Immunoenzymetric Assay For Ige--.
Device ID | K863858 |
510k Number | K863858 |
Device Name: | TANDEM-M IMMUNOENZYMETRIC ASSAY FOR IGE-- |
Classification | Ige, Antigen, Antiserum, Control |
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 | DGC |
CFR Regulation Number | 866.5510 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1986-10-03 |
Decision Date | 1986-11-03 |