The following data is part of a premarket notification filed by Aerscher, Inc. with the FDA for Fht (fecal Heme Test).
| Device ID | K905782 |
| 510k Number | K905782 |
| Device Name: | FHT (FECAL HEME TEST) |
| Classification | Reagent, Occult Blood |
| Applicant | AERSCHER, INC. 527 FEY RD. Chestertown, MD 21620 |
| Contact | Robert Schreiber |
| Correspondent | Robert Schreiber AERSCHER, INC. 527 FEY RD. 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 | 1990-12-21 |
| Decision Date | 1991-05-06 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00693501000220 | K905782 | 000 |