The following data is part of a premarket notification filed by Quantimetrix Corp. with the FDA for Assure Urine Hcg Control.
| Device ID | K941130 |
| 510k Number | K941130 |
| Device Name: | ASSURE URINE HCG CONTROL |
| Classification | Single (specified) Analyte Controls (assayed And Unassayed) |
| Applicant | QUANTIMETRIX CORP. 4955 WEST 145 ST. Hawthorne, CA 90250 -6703 |
| Contact | Evy Johnson |
| Correspondent | Evy Johnson 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 | 1994-03-09 |
| Decision Date | 1994-06-03 |