The following data is part of a premarket notification filed by Quantimetrix Corp. with the FDA for Quantimetrix Ammonia Controls.
| Device ID | K913346 |
| 510k Number | K913346 |
| Device Name: | QUANTIMETRIX AMMONIA CONTROLS |
| Classification | Single (specified) Analyte Controls (assayed And Unassayed) |
| Applicant | QUANTIMETRIX CORP. 4955 WEST 145 ST. Hawthorne, CA 90250 -6703 |
| Contact | John P Tarburton |
| Correspondent | John P Tarburton QUANTIMETRIX CORP. 4955 WEST 145 ST. Hawthorne, CA 90250 -6703 |
| Product Code | JJX |
| CFR Regulation Number | 862.1660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-07-26 |
| Decision Date | 1991-09-25 |