The following data is part of a premarket notification filed by Aerscher Diagnostics with the FDA for Hemaprompt Gastric.
| Device ID | K031356 |
| 510k Number | K031356 |
| Device Name: | HEMAPROMPT GASTRIC |
| Classification | Reagent, Occult Blood |
| Applicant | AERSCHER DIAGNOSTICS 353 HIGH ST. Chestertown, MD 21620 |
| Contact | Robert Schreiber |
| Correspondent | Robert Schreiber AERSCHER DIAGNOSTICS 353 HIGH ST. Chestertown, MD 21620 |
| Product Code | KHE |
| CFR Regulation Number | 864.6550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-04-11 |
| Decision Date | 2003-09-24 |
| Summary: | summary |