The following data is part of a premarket notification filed by Arkray Factory, Inc. with the FDA for Adams A1c Ha-8180v, Calibrator 80.
| Device ID | K162822 |
| 510k Number | K162822 |
| Device Name: | ADAMS A1c HA-8180V, CALIBRATOR 80 |
| Classification | Hemoglobin A1c Test System |
| Applicant | Arkray Factory, Inc. 1480 Koji, Konan-cho Koka-shi, JP 520-3306 |
| Contact | Kazuya Yorimitsu |
| Correspondent | Naveen Thuramalla Akray Factory USA, Inc. 5182 West 76th Street Edina, MN 55439 |
| Product Code | PDJ |
| Subsequent Product Code | JIT |
| Subsequent Product Code | LCP |
| CFR Regulation Number | 862.1373 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-10-07 |
| Decision Date | 2017-06-29 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04987486015147 | K162822 | 000 |
| 04987486015130 | K162822 | 000 |
| 14987486015120 | K162822 | 000 |
| 14987486015113 | K162822 | 000 |
| 14987486015106 | K162822 | 000 |
| 14987486015090 | K162822 | 000 |
| 04987486001973 | K162822 | 000 |