The following data is part of a premarket notification filed by Biocheck, Inc. with the FDA for Biocheck Myoglobin Elisa, Model Bc-1117.
| Device ID | K022660 |
| 510k Number | K022660 |
| Device Name: | BIOCHECK MYOGLOBIN ELISA, MODEL BC-1117 |
| Classification | Amplifier And Signal Conditioner, Biopotential |
| 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 | DRR |
| CFR Regulation Number | 870.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-08-09 |
| Decision Date | 2002-12-19 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00811727013354 | K022660 | 000 |
| 00840239039552 | K022660 | 000 |
| 00850392007176 | K022660 | 000 |
| 00083059070309 | K022660 | 000 |
| 08305900070309 | K022660 | 000 |
| 04048474039559 | K022660 | 000 |