The following data is part of a premarket notification filed by Pointe Scientific, Inc. with the FDA for Chloride Reagent.
| Device ID | K852169 |
| 510k Number | K852169 |
| Device Name: | CHLORIDE REAGENT |
| Classification | Mercuric Thiocyanate, Colorimetry, Chloride |
| Applicant | POINTE SCIENTIFIC, INC. P.O. BOX 8569 Detroit, MI 48224 |
| Contact | Janusz M Szyszko |
| Correspondent | Janusz M Szyszko POINTE SCIENTIFIC, INC. P.O. BOX 8569 Detroit, MI 48224 |
| Product Code | CHJ |
| CFR Regulation Number | 862.1170 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-05-20 |
| Decision Date | 1985-08-21 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00817274021170 | K852169 | 000 |