The following data is part of a premarket notification filed by Diazyme Laboratories with the FDA for Diazyme Homocysteine 2 Reagent Enzymatic Assay Kit, And Calibrators, Model(s) Dzxxxa, Dzxxxa-cal.
Device ID | K071971 |
510k Number | K071971 |
Device Name: | DIAZYME HOMOCYSTEINE 2 REAGENT ENZYMATIC ASSAY KIT, AND CALIBRATORS, MODEL(S) DZXXXA, DZXXXA-CAL |
Classification | Urinary Homocystine (nonquantitative) Test System |
Applicant | DIAZYME LABORATORIES 12889 GREGG COURT Poway, CA 92064 |
Contact | Charles Yu |
Correspondent | Charles Yu DIAZYME LABORATORIES 12889 GREGG COURT Poway, CA 92064 |
Product Code | LPS |
CFR Regulation Number | 862.1377 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2007-07-17 |
Decision Date | 2007-09-17 |