The following data is part of a premarket notification filed by Technimed, Inc. with the FDA for Dimension Whole Blood Cholesterol.
| Device ID | K880723 |
| 510k Number | K880723 |
| Device Name: | DIMENSION WHOLE BLOOD CHOLESTEROL |
| Classification | Enzymatic Esterase--oxidase, Cholesterol |
| Applicant | TECHNIMED, INC. P.O. BOX 5003 4987 N.W. 23RD AVENUE Fort Lauderdale, FL 33310 |
| Contact | Jack Aronowitz |
| Correspondent | Jack Aronowitz TECHNIMED, INC. P.O. BOX 5003 4987 N.W. 23RD AVENUE Fort Lauderdale, FL 33310 |
| Product Code | CHH |
| CFR Regulation Number | 862.1175 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-02-23 |
| Decision Date | 1988-11-08 |