ROTASCREEN
Antigens, Ha (including Ha Control), Adenovirus 1-33
MERCIA DIAGNOSTICS LTD.
The following data is part of a premarket notification filed by Mercia Diagnostics Ltd. with the FDA for Rotascreen.
Pre-market Notification Details
| Device ID | K872568 |
| 510k Number | K872568 |
| Device Name: | ROTASCREEN |
| Classification | Antigens, Ha (including Ha Control), Adenovirus 1-33 |
| Applicant | MERCIA DIAGNOSTICS LTD. MERCIA HOUSEET BROADFORD PARK Guildford, Surrey England, GB Gu4 8ew |
| Contact | Olliver Ph.d. |
| Correspondent | Olliver Ph.d. MERCIA DIAGNOSTICS LTD. MERCIA HOUSEET BROADFORD PARK Guildford, Surrey England, GB Gu4 8ew |
| Product Code | GOB |
| CFR Regulation Number | 866.3020 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-06-29 |
| Decision Date | 1987-09-14 |
Trademark Results [ROTASCREEN]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 ROTASCREEN 73298454 1196665 Live/Registered |
Triple/S Dynamics, Inc. 1981-02-24 |
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