The following data is part of a premarket notification filed by Synermed, Inc. with the FDA for Synermed Phosphorus Reagent Kit.
| Device ID | K912569 |
| 510k Number | K912569 |
| Device Name: | SYNERMED PHOSPHORUS REAGENT KIT |
| Classification | Phosphomolybdate (colorimetric), Inorganic Phosphorus |
| Applicant | SYNERMED, INC. 1688 50TH AVENUE, MONTREAL (LACHINE), Quebec, Canada, CA H8t 2v5 |
| Contact | Marcia J Arentz |
| Correspondent | Marcia J Arentz SYNERMED, INC. 1688 50TH AVENUE, MONTREAL (LACHINE), Quebec, Canada, CA H8t 2v5 |
| Product Code | CEO |
| CFR Regulation Number | 862.1580 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-06-11 |
| Decision Date | 1991-07-17 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05060500091934 | K912569 | 000 |
| 05060500091262 | K912569 | 000 |
| 05060500091255 | K912569 | 000 |
| 05060500091248 | K912569 | 000 |
| 05060500091231 | K912569 | 000 |
| 05060500091224 | K912569 | 000 |
| 05060500091217 | K912569 | 000 |