The following data is part of a premarket notification filed by Roche Diagnostics Corp. with the FDA for Chemstrip 5 Ob, Chemstrip 7 And Chemstrip 10 Md Test Strips.
Device ID | K032437 |
510k Number | K032437 |
Device Name: | CHEMSTRIP 5 OB, CHEMSTRIP 7 AND CHEMSTRIP 10 MD TEST STRIPS |
Classification | Method, Enzymatic, Glucose (urinary, Non-quantitative) |
Applicant | ROCHE DIAGNOSTICS CORP. 9115 HAGUE RD. PO BX 50457 Indianapolis, IN 46250 -0457 |
Contact | Jennifer Tribbett |
Correspondent | Jennifer Tribbett ROCHE DIAGNOSTICS CORP. 9115 HAGUE RD. PO BX 50457 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 | 2003-08-07 |
Decision Date | 2003-10-08 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00075537671603 | K032437 | 000 |
00075537313121 | K032437 | 000 |
00075537018934 | K032437 | 000 |