The following data is part of a premarket notification filed by Tech-co, Inc. with the FDA for Cholesterol.
| Device ID | K863927 |
| 510k Number | K863927 |
| Device Name: | CHOLESTEROL |
| Classification | Enzymatic Esterase--oxidase, Cholesterol |
| Applicant | TECH-CO, INC. 4378 REILLY Troy, MI 48098 |
| Contact | Happy Chen |
| Correspondent | Happy Chen TECH-CO, INC. 4378 REILLY Troy, MI 48098 |
| Product Code | CHH |
| CFR Regulation Number | 862.1175 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-10-08 |
| Decision Date | 1986-11-24 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10673486001471 | K863927 | 000 |
| 10673486001464 | K863927 | 000 |
| 10673486001457 | K863927 | 000 |
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 |