The following data is part of a premarket notification filed by Hybritech, Inc. with the FDA for Tandem-e Lh Immunoenzymetric Assay Kit.
| Device ID | K895094 |
| 510k Number | K895094 |
| Device Name: | TANDEM-E LH IMMUNOENZYMETRIC ASSAY KIT |
| Classification | Radioimmunoassay, Luteinizing Hormone |
| 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 | CEP |
| CFR Regulation Number | 862.1485 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-08-14 |
| Decision Date | 1989-10-31 |