The following data is part of a premarket notification filed by Quantimetrix Corp. with the FDA for Dropper A1c Diabetes Control.
| Device ID | K103744 |
| 510k Number | K103744 |
| Device Name: | DROPPER A1C DIABETES CONTROL |
| Classification | Single (specified) Analyte Controls (assayed And Unassayed) |
| Applicant | QUANTIMETRIX CORP. 2005 MANHATTAN BEACH BLVD. Redondo Beach, CA 90278 -1205 |
| Contact | Kalyna Snylyk |
| Correspondent | Kalyna Snylyk QUANTIMETRIX CORP. 2005 MANHATTAN BEACH BLVD. Redondo Beach, CA 90278 -1205 |
| Product Code | JJX |
| CFR Regulation Number | 862.1660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-12-23 |
| Decision Date | 2011-05-12 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00381930737014 | K103744 | 000 |