The following data is part of a premarket notification filed by Acon Laboratories Co. with the FDA for On-call Plus Blood Glucose Monitoring System.
| Device ID | K090057 |
| 510k Number | K090057 |
| Device Name: | ON-CALL PLUS BLOOD GLUCOSE MONITORING SYSTEM |
| Classification | System, Test, Blood Glucose, Over The Counter |
| Applicant | ACON LABORATORIES CO. 4108 SORRENTO VALLEY BLVD. San Diego, CA 92121 |
| Contact | Richard Lenart |
| Correspondent | Richard Lenart ACON LABORATORIES CO. 4108 SORRENTO VALLEY BLVD. San Diego, CA 92121 |
| Product Code | NBW |
| Subsequent Product Code | CGA |
| Subsequent Product Code | JJX |
| CFR Regulation Number | 862.1345 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-01-08 |
| Decision Date | 2009-04-08 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00682607000135 | K090057 | 000 |
| 20682607535310 | K090057 | 000 |
| 20682607535211 | K090057 | 000 |
| 00682607000159 | K090057 | 000 |
| 00682607000142 | K090057 | 000 |