The following data is part of a premarket notification filed by Precision Systems, Inc. with the FDA for Precision Systems Analette Chemistry Analyzer.
| Device ID | K013654 |
| 510k Number | K013654 |
| Device Name: | PRECISION SYSTEMS ANALETTE CHEMISTRY ANALYZER |
| Classification | Analyzer, Chemistry, Micro, For Clinical Use |
| Applicant | PRECISION SYSTEMS, INC. 16 TECH CIRCLE Natick, MA 01760 |
| Contact | Bill Haden |
| Correspondent | Bill Haden PRECISION SYSTEMS, INC. 16 TECH CIRCLE Natick, MA 01760 |
| Product Code | JJF |
| Subsequent Product Code | CDQ |
| Subsequent Product Code | CEK |
| Subsequent Product Code | CEO |
| Subsequent Product Code | CFJ |
| Subsequent Product Code | CFM |
| Subsequent Product Code | CGA |
| Subsequent Product Code | CHG |
| Subsequent Product Code | CHH |
| Subsequent Product Code | CIG |
| Subsequent Product Code | CIT |
| Subsequent Product Code | CIX |
| Subsequent Product Code | CJE |
| Subsequent Product Code | CJY |
| Subsequent Product Code | CKA |
| Subsequent Product Code | GGX |
| Subsequent Product Code | JFJ |
| Subsequent Product Code | JGJ |
| Subsequent Product Code | JGY |
| Subsequent Product Code | JMO |
| Subsequent Product Code | &nb |
| CFR Regulation Number | 862.2170 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-11-06 |
| Decision Date | 2002-06-05 |
| Summary: | summary |