The following data is part of a premarket notification filed by Home Diagnostics, Inc. with the FDA for Truetrack Smart System Blood Glucose Meter, Blood Glucose Test Strips, And Glucose Control Solutions (low And High).
| Device ID | K032657 |
| 510k Number | K032657 |
| Device Name: | TRUETRACK SMART SYSTEM BLOOD GLUCOSE METER, BLOOD GLUCOSE TEST STRIPS, AND GLUCOSE CONTROL SOLUTIONS (LOW AND HIGH) |
| Classification | System, Test, Blood Glucose, Over The Counter |
| Applicant | HOME DIAGNOSTICS, INC. 2400 N.W. 55TH CT. Fort Lauderdale, FL 33309 |
| Contact | Karen Devincent |
| Correspondent | Karen Devincent HOME DIAGNOSTICS, INC. 2400 N.W. 55TH CT. Fort Lauderdale, FL 33309 |
| Product Code | NBW |
| Subsequent Product Code | CGA |
| Subsequent Product Code | JJX |
| CFR Regulation Number | 862.1345 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-08-28 |
| Decision Date | 2004-03-24 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 50021292008609 | K032657 | 000 |
| 00030034055479 | K032657 | 000 |
| 10021292009288 | K032657 | 000 |
| 00021292008932 | K032657 | 000 |
| 00021292008888 | K032657 | 000 |
| 00021292002091 | K032657 | 000 |
| 00021292008376 | K032657 | 000 |
| 00021292002107 | K032657 | 000 |
| 10021292004573 | K032657 | 000 |
| 10021292003217 | K032657 | 000 |
| 00021292001971 | K032657 | 000 |
| 00021292001797 | K032657 | 000 |
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| 10021292006874 | K032657 | 000 |
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| 10021292006843 | K032657 | 000 |
| 00847717034009 | K032657 | 000 |
| 00096295129489 | K032657 | 000 |
| 50096295111861 | K032657 | 000 |
| 10093351115520 | K032657 | 000 |
| 10087701866804 | K032657 | 000 |
| 10087701405577 | K032657 | 000 |
| 00052569132463 | K032657 | 000 |
| 10050428318017 | K032657 | 000 |
| 10010939755336 | K032657 | 000 |