V-Trend Im Dry-Spot Test
FDA 510(k) K880399 · Texas Immunology, Inc.
510(k) numberK880399
Submission
- Device name
- V-Trend Im Dry-Spot Test
- Applicant
- Texas Immunology, Inc.
Tyler, TX, US - Received
- January 29, 1988
- Decision date
- February 17, 1988
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- KTN – System, Test, Infectious Mononucleosis
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.5640
- Specialty
- Immunology
Other 510(k)s with product code KTN
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K181436 | OSOM Mono Test; Sure Vue Signature Mono; ImmunoCard STAT Mono; Cardinal Health Mono II…KTN · Special | SEKISUI Diagnostics, LLC | 06/22/2018SE |
| K042272 | Acon Mononucleosis Rapid Test Strip (Whole Blood/Serum/Plasma)KTN · Traditional | ACON Laboratories, Inc. | 02/28/2005SE |
| K030215 | Biorapid MononucleosisKTN · Traditional | Instrumentation Laboratory CO | 02/24/2003SE |
| K012901 | Color-MonogenKTN · Traditional | Instrumentation Laboratory CO | 09/27/2001SE |
| K982634 | Dryspot Infectious Mononucleosis KitKTN · Traditional | Oxoid , Ltd. | 01/28/1999SE |
| K981946 | Clearview ImKTN · Traditional | Unipath , Ltd. | 12/10/1998SE |
| K972457 | Monocol/Lex-Im TestKTN · Traditional | Immunostics Inc., | 12/01/1997SE |
| K972231 | Osom Mono Test 143KTN · Traditional | Wyntek Diagnostics, Inc. | 08/26/1997SE |
| K963425 | Genzyme Diagnostics Contrast MonoKTN · Traditional | Genzyme Diagnostics | 02/25/1997SE |
| K961024 | Biosign Mono-Plus Wb,Biosign Mono Wb,Mono-Plus Wb,Accusign Mono WBKTN · Traditional | Princeton BioMeditech Corp. | 02/04/1997SE |
More from Princeton BioMeditech Corp.
| 510(k) | Device | Decision |
|---|---|---|
| K991465 | Drug StopMVO · Traditional | 12/10/1999SE |
| K980153 | Drug CheckDIO · Traditional | 03/27/1998SE |
| K973208 | First SignLCX · Traditional | 10/20/1997SE |
| K972094 | Target Cardiac Troponin I TestMMI · Traditional | 07/23/1997SE |
| K963680 | Target Myoglobin TestDDR · Traditional | 02/06/1997SE |
| K912246 | Target Microalbuminuria TestJIR · Traditional | 07/19/1991SE |
| K910073 | Target Aso TestGTQ · Traditional | 05/21/1991SE |
| K904105 | V-Trend Target RF TestDHR · Traditional | 10/15/1990SE |
| K892231 | V-Trend Target CRP TestDCN · Traditional | 04/21/1989SE |
| K890423 | V-Trend Target CRP TestDCK · Traditional | 02/17/1989SE |
Questions and answers
When was V-Trend Im Dry-Spot Test cleared by the FDA?
V-Trend Im Dry-Spot Test (K880399) received a 510(k) decision of Substantially Equivalent on February 17, 1988, 19 days after the submission was received.
What is the product code of K880399?
The FDA product code is KTN – System, Test, Infectious Mononucleosis, a Class II (moderate risk) device regulated under 21 CFR 866.5640.