The following data is part of a premarket notification filed by Boehringer Mannheim Corp. with the FDA for Chemstrip 101 Urine Analyzer.
| Device ID | K983510 |
| 510k Number | K983510 |
| Device Name: | CHEMSTRIP 101 URINE ANALYZER |
| Classification | Automated Urinalysis System |
| Applicant | BOEHRINGER MANNHEIM CORP. 9115 HAGUE RD. Indianapolis, IN 46250 -0457 |
| Contact | Jennifer Tribbett |
| Correspondent | Jennifer Tribbett BOEHRINGER MANNHEIM CORP. 9115 HAGUE RD. Indianapolis, IN 46250 -0457 |
| Product Code | KQO |
| Subsequent Product Code | CDM |
| Subsequent Product Code | CEN |
| Subsequent Product Code | JIL |
| Subsequent Product Code | JIN |
| Subsequent Product Code | JIO |
| Subsequent Product Code | JIR |
| Subsequent Product Code | JJB |
| Subsequent Product Code | JMT |
| Subsequent Product Code | JRE |
| Subsequent Product Code | LJX |
| CFR Regulation Number | 862.2900 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-10-07 |
| Decision Date | 1998-10-27 |
| Summary: | summary |