The following data is part of a premarket notification filed by Boehringer Mannheim Corp. with the FDA for Chemstrip(r) 10 With Sg Urine Test Strips.
| Device ID | K896454 |
| 510k Number | K896454 |
| Device Name: | CHEMSTRIP(R) 10 WITH SG URINE TEST STRIPS |
| Classification | Method, Enzymatic, Glucose (urinary, Non-quantitative) |
| Applicant | BOEHRINGER MANNHEIM CORP. 9115 HAGUE RD. Indianapolis, IN 46250 -0457 |
| Contact | Cheri Emmons |
| Correspondent | Cheri Emmons BOEHRINGER MANNHEIM CORP. 9115 HAGUE RD. Indianapolis, IN 46250 -0457 |
| Product Code | JIL |
| Subsequent Product Code | CDM |
| Subsequent Product Code | CEN |
| 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 | 862.1340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-11-09 |
| Decision Date | 1990-01-11 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00075537171455 | K896454 | 000 |
| 00075537171097 | K896454 | 000 |
| 00075537007433 | K896454 | 000 |