The following data is part of a premarket notification filed by Diazyme Laboratories with the FDA for Diazyme Homocysteine Poc Test Kit.
| Device ID | K121053 |
| 510k Number | K121053 |
| Device Name: | DIAZYME HOMOCYSTEINE POC TEST KIT |
| Classification | Urinary Homocystine (nonquantitative) Test System |
| Applicant | DIAZYME LABORATORIES 12889 GREGG COURT Poway, CA 92064 |
| Contact | Abhijit Datta |
| Correspondent | Abhijit Datta DIAZYME LABORATORIES 12889 GREGG COURT Poway, CA 92064 |
| Product Code | LPS |
| CFR Regulation Number | 862.1377 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-04-06 |
| Decision Date | 2012-07-31 |
| Summary: | summary |