Cholesterol
Enzymatic Esterase--oxidase, Cholesterol
RANDOX LABORATORIES, LTD.
The following data is part of a premarket notification filed by Randox Laboratories, Ltd. with the FDA for Cholesterol.
Pre-market Notification Details
| Device ID | K150654 |
| 510k Number | K150654 |
| Device Name: | Cholesterol |
| Classification | Enzymatic Esterase--oxidase, Cholesterol |
| Applicant | RANDOX LABORATORIES, LTD. 55 DIAMOND ROAD Crumlin, GB Bt29 4qy |
| Contact | Pauline Armstrong |
| Correspondent | Pauline Armstrong RANDOX LABORATORIES, LTD. 55 DIAMOND ROAD Crumlin, GB Bt29 4qy |
| Product Code | CHH |
| CFR Regulation Number | 862.1175 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-03-13 |
| Decision Date | 2015-09-29 |
| Summary: | summary |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00630414596327 | K150654 | 000 |
Trademark Results [Cholesterol]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 CHOLESTEROL 73837165 1611220 Dead/Cancelled |
KSF MEDICAL PUBLISHING COMPANY, INC. 1989-11-09 |
 CHOLESTEROL 73783518 not registered Dead/Abandoned |
DAWN FOOD PRODUCTS, INC. 1989-02-27 |
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