The following data is part of a premarket notification filed by Diazyme Laboratories with the FDA for Diazyme Lipoprotein (a) Calibrator Set, Control Set.
| Device ID | K131556 |
| 510k Number | K131556 |
| Device Name: | DIAZYME LIPOPROTEIN (A) CALIBRATOR SET, CONTROL SET |
| Classification | Calibrator, Secondary |
| 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 | JIT |
| CFR Regulation Number | 862.1150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-05-29 |
| Decision Date | 2013-06-26 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00811727015594 | K131556 | 000 |