D-CHEM
Analyzer, Chemistry (photometric, Discrete), For Clinical Use
PHOTEC DIAGNOSTICS, INC.
The following data is part of a premarket notification filed by Photec Diagnostics, Inc. with the FDA for D-chem.
Pre-market Notification Details
| 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 |
Trademark Results [D-CHEM]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 D-CHEM 73765566 1552672 Dead/Cancelled |
PHOTEST DIAGNOSTICS, INC. 1988-11-25 |
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