V-Trend QC TDM Control Serum 1,2,3.
FDA 510(k) K862817 · Texas Immunology, Inc.
510(k) numberK862817
Submission
- Device name
- V-Trend QC TDM Control Serum 1,2,3.
- Applicant
- Texas Immunology, Inc.
Tyler, TX, US - Received
- July 24, 1986
- Decision date
- August 19, 1986
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- DIF – Drug Mixture Control Materials
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.3280
- Specialty
- Clinical Toxicology
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| K904105 | V-Trend Target RF TestDHR · Traditional | 10/15/1990SE |
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Questions and answers
When was V-Trend QC TDM Control Serum 1,2,3. cleared by the FDA?
V-Trend QC TDM Control Serum 1,2,3. (K862817) received a 510(k) decision of Substantially Equivalent on August 19, 1986, 26 days after the submission was received.
What is the product code of K862817?
The FDA product code is DIF – Drug Mixture Control Materials, a Class I (low risk) device regulated under 21 CFR 862.3280.