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 |