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 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00817089021464 | K071971 | 000 |
| 00817089020955 | K071971 | 000 |
| 00817089020948 | K071971 | 000 |
| 00817089020306 | K071971 | 000 |