The following data is part of a premarket notification filed by Boehringer Mannheim Corp. with the FDA for Chemstrip Micral Urine Test Strips.
| Device ID | K954346 |
| 510k Number | K954346 |
| Device Name: | CHEMSTRIP MICRAL URINE TEST STRIPS |
| Classification | Indicator Method, Protein Or Albumin (urinary, Non-quant.) |
| Applicant | BOEHRINGER MANNHEIM CORP. 9115 HAGUE RD. P.O. BOX 50457 Indianapolis, IN 46250 -0457 |
| Contact | Michael Flis |
| Correspondent | Michael Flis BOEHRINGER MANNHEIM CORP. 9115 HAGUE RD. P.O. BOX 50457 Indianapolis, IN 46250 -0457 |
| Product Code | JIR |
| CFR Regulation Number | 862.1645 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-09-18 |
| Decision Date | 1995-10-26 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00075537171462 | K954346 | 000 |