The following data is part of a premarket notification filed by Diazyme Laboratories with the FDA for Diazyme Glycated Serum Protein Assay / Calibrator Kit / Control Kit.
| Device ID | K110188 |
| 510k Number | K110188 |
| Device Name: | DIAZYME GLYCATED SERUM PROTEIN ASSAY / CALIBRATOR KIT / CONTROL KIT |
| Classification | Assay, Glycosylated Hemoglobin |
| 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 | LCP |
| Subsequent Product Code | JIT |
| Subsequent Product Code | JJX |
| CFR Regulation Number | 864.7470 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-01-24 |
| Decision Date | 2011-05-17 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05055273208726 | K110188 | 000 |
| 05055273208733 | K110188 | 000 |