The following data is part of a premarket notification filed by Enzymatics C/o Burditt,bowles,radzius & Ruberry with the FDA for Enzymatics, Inc., Total Cholesterol Test.
| Device ID | K911692 |
| 510k Number | K911692 |
| Device Name: | ENZYMATICS, INC., TOTAL CHOLESTEROL TEST |
| Classification | Enzymatic Esterase--oxidase, Cholesterol |
| Applicant | ENZYMATICS C/O BURDITT,BOWLES,RADZIUS & RUBERRY 355 BUSINESS CENTER DR. Horsham, PA 19044 |
| Contact | Christopher Zalesky |
| Correspondent | Christopher Zalesky ENZYMATICS C/O BURDITT,BOWLES,RADZIUS & RUBERRY 355 BUSINESS CENTER DR. Horsham, PA 19044 |
| Product Code | CHH |
| CFR Regulation Number | 862.1175 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-04-16 |
| Decision Date | 1991-08-16 |