The following data is part of a premarket notification filed by Cirrus Diagnostics, Inc. with the FDA for Crp Lipid Reagent Test Pack.
| Device ID | K905648 |
| 510k Number | K905648 |
| Device Name: | CRP LIPID REAGENT TEST PACK |
| Classification | Enzymatic Esterase--oxidase, Cholesterol |
| Applicant | CIRRUS DIAGNOSTICS, INC. P.O. BOX 15 Chester, NJ 07930 |
| Contact | Robert Fennell |
| Correspondent | Robert Fennell CIRRUS DIAGNOSTICS, INC. P.O. BOX 15 Chester, NJ 07930 |
| Product Code | CHH |
| CFR Regulation Number | 862.1175 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-12-17 |
| Decision Date | 1991-03-06 |