HEMAPROMPT
Reagent, Occult Blood
AERSCHER DIAGNOSTICS
The following data is part of a premarket notification filed by Aerscher Diagnostics with the FDA for Hemaprompt.
Pre-market Notification Details
| Device ID | K981661 |
| 510k Number | K981661 |
| Device Name: | HEMAPROMPT |
| 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 | 1998-05-06 |
| Decision Date | 1998-09-15 |
| Summary: | summary |
Trademark Results [HEMAPROMPT]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 HEMAPROMPT 74376539 1849175 Live/Registered |
AERSCHER LLC 1993-04-06 |
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