The following data is part of a premarket notification filed by Precision Systems, Inc. with the FDA for Precision Systems Analette Chemistry Analyzer Stanbio Laboratory Reagents.
| Device ID | K024182 |
| 510k Number | K024182 |
| Device Name: | PRECISION SYSTEMS ANALETTE CHEMISTRY ANALYZER STANBIO LABORATORY REAGENTS |
| Classification | Urease And Glutamic Dehydrogenase, Urea Nitrogen |
| 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 | CDQ |
| Subsequent Product Code | CEO |
| Subsequent Product Code | CGA |
| Subsequent Product Code | CGS |
| Subsequent Product Code | CGX |
| Subsequent Product Code | CHH |
| Subsequent Product Code | CHJ |
| Subsequent Product Code | CIG |
| Subsequent Product Code | CIT |
| Subsequent Product Code | CIX |
| Subsequent Product Code | CJE |
| Subsequent Product Code | CJY |
| Subsequent Product Code | JGJ |
| Subsequent Product Code | JGY |
| Subsequent Product Code | JJF |
| Subsequent Product Code | KNK |
| CFR Regulation Number | 862.1770 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-12-19 |
| Decision Date | 2003-03-03 |
| Summary: | summary |