The following data is part of a premarket notification filed by Biocheck, Inc. with the FDA for Biocheck Ige Elisa, Model Bc-1035.
| Device ID | K992528 |
| 510k Number | K992528 |
| Device Name: | BIOCHECK IGE ELISA, MODEL BC-1035 |
| Classification | Ige, Antigen, Antiserum, Control |
| Applicant | BIOCHECK, INC. 9418 LASAINE AVE. Northridge, CA 91325 |
| Contact | Robin J Hellen |
| Correspondent | Robin J Hellen BIOCHECK, INC. 9418 LASAINE AVE. Northridge, CA 91325 |
| Product Code | DGC |
| CFR Regulation Number | 866.5510 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-07-28 |
| Decision Date | 1999-09-21 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00811727013330 | K992528 | 000 |
| B24225IGEHUE010 | K992528 | 000 |
| 00850392007350 | K992528 | 000 |
| 00840239017888 | K992528 | 000 |
| 04048474017885 | K992528 | 000 |