The following data is part of a premarket notification filed by Acon Laboratories, Inc. with the FDA for Mission Plus Hb Hemoglobin Testing System.
| Device ID | K122553 |
| 510k Number | K122553 |
| Device Name: | MISSION PLUS HB HEMOGLOBIN TESTING SYSTEM |
| Classification | System, Hemoglobin, Automated |
| Applicant | ACON LABORATORIES, INC. 10125 MESA RIM ROAD San Diego, CA 92121 |
| Contact | Qiyi Xie |
| Correspondent | Qiyi Xie ACON LABORATORIES, INC. 10125 MESA RIM ROAD San Diego, CA 92121 |
| Product Code | GKR |
| CFR Regulation Number | 864.5620 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-08-21 |
| Decision Date | 2013-08-05 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00682607000180 | K122553 | 000 |
| 20682607610567 | K122553 | 000 |
| 20682607610543 | K122553 | 000 |
| 20682607610536 | K122553 | 000 |
| 20682607200027 | K122553 | 000 |
| 20682607200010 | K122553 | 000 |
| 00682607000227 | K122553 | 000 |
| 00682607000203 | K122553 | 000 |
| 00682607000197 | K122553 | 000 |