Data / Medical devices / China / Chong Qing Teco Huayi Pharm. Co.
Chong Qing Teco Huayi Pharm. Co.: FDA-registered device maker in Shapingba Dist., Chongqing, China, 15 510(k) clearances
Chong Qing Teco Huayi Pharm. Co. is registered with the FDA (registration 3006621318) in Shapingba Dist., Chongqing, China. It lists 18 device types. The FDA files 15 510(k) clearances under its listings, the newest dated July 22, 2016. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3006621318
- Address
- 1st Std. Workshop 2-402, No. 98, Xiyuan 2nd Road, Shapingba Dist., Chongqing 401332, Shapingba Dist., Chongqing, China, 401332
- Owner or operator
- TECO DIAGNOSTICS (1832216)
- Roles
- Contract manufacturer, Manufacturer, Repackager or relabeler, Specification developer
- First device listed
- November 6, 2006
- Registered through
- 2026
- Brand names listed
- Cliawaived 10SG, ONE STEP PREGNANCY CARD TEST, ONE-STEP DIPSTICK PREGNANCY TEST, One-step combo pregnancy dipstick test, One-step urine/serum pregnancy card test, Pregnancy HCG test midstream, TC-3300 Analyzer system, TC-84 analyzer system and more
Devices it lists
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| July 22, 2016 | K160372 | URITEK TC-201 URINE CHEMISTRY TEST SYSTEM | JIL | Substantially Equivalent | Teco Diagnostics, Inc. | accessdata.fda.gov |
| March 7, 2016 | K152835 | URITEK TC-201 URINE CHEMISTRY TEST SYSTEM | JFY | Substantially Equivalent | Teco Diagnostics, Inc. | accessdata.fda.gov |
| October 2, 2015 | K150063 | One Step hCG Pregnancy Test | LCX | Substantially Equivalent | Coretests, Inc. | accessdata.fda.gov |
| July 24, 2015 | K141289 | TC-THUNDERBOLT AUTOMATED URINE ANALYZER SYSTEM AND TC-THUNDERBOLT URS-10 STRIPS | JIL | Substantially Equivalent | Teco Diagnostics | accessdata.fda.gov |
| February 4, 2011 | K101673 | URITEK TC-101 URINE ANALYZER, URINE REAGENT STRIPS 10, MODELS TC-101, URS-10 | JIL | Substantially Equivalent | Teco Diagnostics | accessdata.fda.gov |
| July 14, 2006 | K061065 | FECAL OCCULT BLOOD CARD TEST, MODEL F735-A, FECAL OCCULT BLOOD CARD KIT, MODEL F735-25 | KHE | Substantially Equivalent | Teco Diagnostics | accessdata.fda.gov |
| August 16, 2005 | K051526 | URITEK-720+ URINE ANALYZER | KQO | Substantially Equivalent | Teco Diagnostics | accessdata.fda.gov |
| April 26, 2001 | K003987 | URS-1K (KETONE TESST) | JIN | Substantially Equivalent | Teco Diagnostics | accessdata.fda.gov |
| April 8, 1997 | K970250 | CLINISTRIP | JIL | Substantially Equivalent | Teco Diagnostics | accessdata.fda.gov |
| February 11, 1997 | K964536 | ONE-STEP DIPSTICK PREGNANCY TEST | JHI | Substantially Equivalent | Teco Diagnostics | accessdata.fda.gov |
| February 11, 1997 | K964462 | ONE-STEP URINE/SERUM COMNO PREGNANCY DIPSTICK TEST | JHI | Substantially Equivalent | Teco Diagnostics | accessdata.fda.gov |
| February 11, 1997 | K964461 | ONE -STEP URINE/SERUM COMBO PREGNANCY CARD TEST | JHI | Substantially Equivalent | Teco Diagnostics | accessdata.fda.gov |
| April 15, 1994 | K936031 | ONE STEP PREGNANCY TEST | JHI | Substantially Equivalent | Teco Diagnostics | accessdata.fda.gov |
| March 1, 1990 | K900224 | STAT FAX(TM)-2100 | JJQ | Substantially Equivalent | Awareness Technology, Inc. | accessdata.fda.gov |
| September 9, 1988 | K882938 | STAT FAX(TM) | JJQ | Substantially Equivalent | Awareness Technology, Inc. | accessdata.fda.gov |
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Updated July 22, 2016. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.