The following data is part of a premarket notification filed by Chem-elec, Inc. with the FDA for Solid Phase Deter Serum Cholesterol Fr Whole Blood.
| Device ID | K864159 |
| 510k Number | K864159 |
| Device Name: | SOLID PHASE DETER SERUM CHOLESTEROL FR WHOLE BLOOD |
| Classification | Enzymatic Esterase--oxidase, Cholesterol |
| Applicant | CHEM-ELEC, INC. P.O. BOX 372 North Webster, IN 46555 |
| Contact | Stephen J Jones |
| Correspondent | Stephen J Jones CHEM-ELEC, INC. P.O. BOX 372 North Webster, IN 46555 |
| Product Code | CHH |
| CFR Regulation Number | 862.1175 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-10-23 |
| Decision Date | 1988-06-10 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00737051548327 | K864159 | 000 |