The following data is part of a premarket notification filed by Clinical Diagnostics, Inc. with the FDA for Glucochek Pocketlab.
Device ID | K951457 |
510k Number | K951457 |
Device Name: | GLUCOCHEK POCKETLAB |
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 | 1995-03-29 |
Decision Date | 1996-02-22 |