The following data is part of a premarket notification filed by Waters Chromatography Division with the FDA for Waters Pico Tag Chem Pack/free Amino Acid Analysis.
| Device ID | K943978 |
| 510k Number | K943978 |
| Device Name: | WATERS PICO TAG CHEM PACK/FREE AMINO ACID ANALYSIS |
| Classification | Analyzer, Chemistry, Micro, For Clinical Use |
| Applicant | WATERS CHROMATOGRAPHY DIVISION 34 MAPLE ST. Milford, MA 01757 |
| Contact | Marquand S Ransom |
| Correspondent | Marquand S Ransom WATERS CHROMATOGRAPHY DIVISION 34 MAPLE ST. Milford, MA 01757 |
| Product Code | JJF |
| CFR Regulation Number | 862.2170 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-08-16 |
| Decision Date | 1995-05-02 |