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 |