The following data is part of a premarket notification filed by Amira Medical, Inc. with the FDA for Atlast Glucose Control Solution.
| Device ID | K991075 |
| 510k Number | K991075 |
| Device Name: | ATLAST GLUCOSE CONTROL SOLUTION |
| Classification | Single (specified) Analyte Controls (assayed And Unassayed) |
| Applicant | AMIRA MEDICAL, INC. 4742 SCOTTS VALLEY DR. Scotts Valley, CA 95066 |
| Contact | Nina Peled |
| Correspondent | Nina Peled AMIRA MEDICAL, INC. 4742 SCOTTS VALLEY DR. Scotts Valley, CA 95066 |
| Product Code | JJX |
| CFR Regulation Number | 862.1660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-03-31 |
| Decision Date | 1999-05-10 |
| Summary: | summary |