The following data is part of a premarket notification filed by Clinical Controls, Inc. with the FDA for Whole Blood Glucose Control Level 1,2,and 3/whole Blood Glucose Linearity Control-level1,2,3,4,5,and 6.
| Device ID | K964278 |
| 510k Number | K964278 |
| Device Name: | WHOLE BLOOD GLUCOSE CONTROL LEVEL 1,2,AND 3/WHOLE BLOOD GLUCOSE LINEARITY CONTROL-LEVEL1,2,3,4,5,AND 6 |
| Classification | Single (specified) Analyte Controls (assayed And Unassayed) |
| Applicant | CLINICAL CONTROLS, INC. 750 FARROLL RD. SUITE B Grover Beach, CA 93433 |
| Contact | James F Godfrey |
| Correspondent | James F Godfrey CLINICAL CONTROLS, INC. 750 FARROLL RD. SUITE B Grover Beach, CA 93433 |
| Product Code | JJX |
| CFR Regulation Number | 862.1660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-10-28 |
| Decision Date | 1996-11-22 |