ROM PLUS
Immunoassay For Detection Of Amniotic Fluid Protein(s).
CLINICAL INNOVATIONS, LLC
The following data is part of a premarket notification filed by Clinical Innovations, Llc with the FDA for Rom Plus.
Pre-market Notification Details
| Device ID | K110605 |
| 510k Number | K110605 |
| Device Name: | ROM PLUS |
| Classification | Immunoassay For Detection Of Amniotic Fluid Protein(s). |
| Applicant | CLINICAL INNOVATIONS, LLC 747 WEST 4170 SOUTH Murray, UT 84123 |
| Contact | Dean Wallace |
| Correspondent | Dean Wallace CLINICAL INNOVATIONS, LLC 747 WEST 4170 SOUTH Murray, UT 84123 |
| Product Code | NQM |
| CFR Regulation Number | 862.1550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-03-02 |
| Decision Date | 2011-11-23 |
| Summary: | summary |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10814247020953 | K110605 | 000 |
| 20814247020424 | K110605 | 000 |
| 10814247020434 | K110605 | 000 |
| 20814247020448 | K110605 | 000 |
| 20814247020455 | K110605 | 000 |
| 20814247020462 | K110605 | 000 |
| 10814247020854 | K110605 | 000 |
| 10814247020892 | K110605 | 000 |
| 10814247020922 | K110605 | 000 |
| 00814247020406 | K110605 | 000 |
Trademark Results [ROM PLUS]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 ROM PLUS 85250892 4151217 Live/Registered |
Clinical Innovations, LLC 2011-02-24 |
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