The following data is part of a premarket notification filed by American Monitor Corp. with the FDA for Bio-interference Blanking Material, Am Cat. #2052.
| Device ID | K872073 |
| 510k Number | K872073 |
| Device Name: | BIO-INTERFERENCE BLANKING MATERIAL, AM CAT. #2052 |
| Classification | Calibrator, Secondary |
| Applicant | AMERICAN MONITOR CORP. P.O. BOX 68505 Indianapolis, IN 46268 |
| Contact | Luann Ochs |
| Correspondent | Luann Ochs AMERICAN MONITOR CORP. P.O. BOX 68505 Indianapolis, IN 46268 |
| Product Code | JIT |
| CFR Regulation Number | 862.1150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-05-29 |
| Decision Date | 1987-09-11 |