The following data is part of a premarket notification filed by Photec Diagnostics, Inc. with the FDA for D-chem.
Device ID | K882307 |
510k Number | K882307 |
Device Name: | D-CHEM |
Classification | Analyzer, Chemistry (photometric, Discrete), For Clinical Use |
Applicant | PHOTEC DIAGNOSTICS, INC. 101 EAST MAIN ST. Little Falls, NJ 07424 |
Contact | Barry Mcdonald |
Correspondent | Barry Mcdonald PHOTEC DIAGNOSTICS, INC. 101 EAST MAIN ST. Little Falls, NJ 07424 |
Product Code | JJE |
CFR Regulation Number | 862.2160 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1988-06-03 |
Decision Date | 1988-08-02 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
D-CHEM 73765566 1552672 Dead/Cancelled |
PHOTEST DIAGNOSTICS, INC. 1988-11-25 |