The following data is part of a premarket notification filed by Clinical Diagnostics, Inc. with the FDA for Glucochek.
| Device ID | K940215 |
| 510k Number | K940215 |
| Device Name: | GLUCOCHEK |
| Classification | Glucose Oxidase, Glucose |
| Applicant | CLINICAL DIAGNOSTICS, INC. 132 MAIN STREET, SUITE A Chester, SC 29706 |
| Contact | Charles F Neilson |
| Correspondent | Charles F Neilson CLINICAL DIAGNOSTICS, INC. 132 MAIN STREET, SUITE A 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 | 1994-01-14 |
| Decision Date | 1995-01-17 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() GLUCOCHEK 75243156 not registered Dead/Abandoned |
Clinical Diagnostics, Inc. 1997-02-12 |
![]() GLUCOCHEK 73319811 not registered Dead/Abandoned |
Medistron Limited 1981-07-20 |