The following data is part of a premarket notification filed by Teco Diagnostics with the FDA for Tc-thunderbolt Automated Urine Analyzer System And Tc-thunderbolt Urs-10 Strips.
Device ID | K141289 |
510k Number | K141289 |
Device Name: | TC-THUNDERBOLT AUTOMATED URINE ANALYZER SYSTEM AND TC-THUNDERBOLT URS-10 STRIPS |
Classification | Method, Enzymatic, Glucose (urinary, Non-quantitative) |
Applicant | TECO DIAGNOSTICS 1268 NORTH LAKEVIEW AVE. Anaheim, CA 92807 |
Contact | Aquil Merchant |
Correspondent | Aquil Merchant TECO DIAGNOSTICS 1268 NORTH LAKEVIEW AVE. Anaheim, CA 92807 |
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 | KQO |
Subsequent Product Code | LJX |
CFR Regulation Number | 862.1340 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2014-05-19 |
Decision Date | 2015-07-24 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
10673486000665 | K141289 | 000 |
10673486000528 | K141289 | 000 |