The following data is part of a premarket notification filed by Catachem, Inc. with the FDA for 340-chloride For Discrete Random Access Analyzer.
| Device ID | K945408 |
| 510k Number | K945408 |
| Device Name: | 340-CHLORIDE FOR DISCRETE RANDOM ACCESS ANALYZER |
| Classification | Mercuric Thiocyanate, Colorimetry, Chloride |
| Applicant | CATACHEM, INC. P.O. BOX 6216 70 HAWLEY AVENUE Bridgeport, CT 06606 -0216 |
| Contact | Luis P Leon |
| Correspondent | Luis P Leon CATACHEM, INC. P.O. BOX 6216 70 HAWLEY AVENUE Bridgeport, CT 06606 -0216 |
| Product Code | CHJ |
| CFR Regulation Number | 862.1170 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-11-03 |
| Decision Date | 1995-02-22 |