The following data is part of a premarket notification filed by Chem-elec, Inc. with the FDA for Chemcard Glucose Test.
| Device ID | K943503 |
| 510k Number | K943503 |
| Device Name: | CHEMCARD GLUCOSE TEST |
| Classification | Glucose Oxidase, Glucose |
| Applicant | CHEM-ELEC, INC. P.O. BOX 372 North Webster, IN 46555 |
| Contact | William E Woenker |
| Correspondent | William E Woenker CHEM-ELEC, INC. P.O. BOX 372 North Webster, IN 46555 |
| Product Code | CGA |
| CFR Regulation Number | 862.1345 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-07-20 |
| Decision Date | 1996-07-23 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00737051736922 | K943503 | 000 |