The following data is part of a premarket notification filed by Clinical Diagnostics, Inc. with the FDA for Glucochek Pocketlab Ii Blood Glucose System.
| Device ID | K971653 |
| 510k Number | K971653 |
| Device Name: | GLUCOCHEK POCKETLAB II BLOOD GLUCOSE SYSTEM |
| Classification | Glucose Oxidase, Glucose |
| Applicant | CLINICAL DIAGNOSTICS, INC. 609 COLUMBIA RD. Chester, SC 29706 |
| Contact | Rhonda P Blanton |
| Correspondent | Rhonda P Blanton CLINICAL DIAGNOSTICS, INC. 609 COLUMBIA RD. Chester, SC 29706 |
| Product Code | CGA |
| CFR Regulation Number | 862.1345 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-05-06 |
| Decision Date | 1998-01-02 |