The following data is part of a premarket notification filed by Quantimetrix Corp. with the FDA for Sweat Controls For Cystic Fibrosis Testing.
| Device ID | K943925 |
| 510k Number | K943925 |
| Device Name: | SWEAT CONTROLS FOR CYSTIC FIBROSIS TESTING |
| Classification | Electrolyte 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 | JJR |
| CFR Regulation Number | 862.1660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-08-12 |
| Decision Date | 1994-10-04 |