K Tek
Galvez, LA
K Tek appears in FDA device records in Galvez, LA. FDA records list no 510(k) clearances, no PMA records and no registered establishments. As of , FDA records show 7 recalls for this company.
FDA records held for this company
- 510(k) clearances
- 0
- PMA records
- 0
- Recall records
- 7
- Registered establishments
- 0
510(k) clearance history
No 510(k) clearance records for this company in the ingested FDA data.
No 510(k) clearance records in the ingested FDA data.
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
No FDA product codes recorded against this company.
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-1126-2007 | Laser Distance and Level Transmitters, Model No. LM02, K-Teck, 18321 Swamp road, Prairieville, LA 70769 | Failure to comply with Federal Laser Product Performance Standards (21 CFR 1040.10, 1040.11, 1002.10-improper classification, incomplete labeling, incomplete user information and failure to submit required product reports) | Terminated | ||
| Z-1125-2007 | Laser Distance and Level Transmitters, Model No. LM200, K-Tek, Prairieville, LA 70769 | Failure to comply with Federal Laser Product Performance Standards (21 CFR 1040.10, 1040.11, 1002.10-improper classification, incomplete labeling, incomplete user information and failure to submit required product reports) | Terminated | ||
| Z-1124-2007 | Laser Distance and Level Transmitters, Model No. LT200, ASI, Housotn, TX 77024 | Failure to comply with Federal Laser Product Performance Standards (21 CFR 1040.10, 1040.11, 1002.10-improper classification, incomplete labeling, incomplete user information and failure to submit required product reports) | Terminated | ||
| Z-1123-2007 | Laser Meter, Model No. LTM80, K-TEK, Prairieville, LA 70769 | Failure to comply with Federal Laser Product Performance Standards (21 CFR 1040.10, 1040.11, 1002.10-improper classification, incomplete labeling, incomplete user information and failure to submit required product reports) | Terminated | ||
| Z-1122-2007 | LaserTrak, Model No. LT80, ASI, Houston, TX 77024 | Failure to comply with Federal Laser Product Performance Standards (21 CFR 1040.10, 1040.11, 1002.10-improper classification, incomplete labeling, incomplete user information and failure to submit required product reports) | Terminated | ||
| Z-1121-2007 | Laser Level Transmitters, Model No. LM4C, K-TEK, 18321 Swamp Road, Prairieville, LA 70769 | Failure to comply with Federal Laser Product Performance Standards (21 CFR 1040.10, 1040.11, 1002.10-improper classification, incomplete labeling, incomplete user information and failure to submit required product reports) | Terminated | ||
| Z-1120-2007 | Laser Distance and Level Transmitters, Model No. LT4C, ASI, 8570 Katy Freeway, Suite 117, Houston, TX 77024 | Failure to comply with Federal Laser Product Performance Standards (21 CFR 1040.10, 1040.11, 1002.10-improper classification, incomplete labeling, incomplete user information and failure to submit required product reports) | Terminated |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain