Osom Mono Test 143
FDA 510(k) K972231 · Wyntek Diagnostics, Inc.
510(k) numberK972231
Submission
- Device name
- Osom Mono Test 143
- Applicant
- Wyntek Diagnostics, Inc.
San Diego, CA, US - Received
- June 16, 1997
- Decision date
- August 26, 1997
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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 |
| 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 |
| K961550 | Qualitrol Mono Control Serum SetKTN · Traditional | Consolidated Technologies, Inc. | 09/24/1996SE |
More from Consolidated Technologies, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K992658 | Osom Ultra Strep a Test, Model 147GTY · Traditional | 01/18/2000SE |
| K990578 | Osom Card II Hcg-Urine Test, Model 102JHI · Traditional | 03/09/1999SE |
| K990576 | Osom Card Pregnancy Test, Model 103LCX · Traditional | 03/09/1999SE |
| K974159 | Osom Hcg-Urine Test Model 101JHI · Traditional | 12/24/1997SE |
| K973879 | Osom Card Hcg-Urine TestJHI · Traditional | 11/04/1997SE |
| K965227 | Osom Classic Hcg-Urine Test (115)JHI · Traditional | 02/04/1997SE |
| K965184 | Perfecta Pregnancy TestLCX · Traditional | 02/04/1997SE |
| K961423 | Osom Strep a TestGTZ · Traditional | 10/11/1996SE |
| K955141 | Osom HCG Combo TestJJX · Traditional | 12/06/1995SE |
| K954178 | Osom Pregnancy TestLCX · Traditional | 10/23/1995SE |
Questions and answers
When was Osom Mono Test 143 cleared by the FDA?
Osom Mono Test 143 (K972231) received a 510(k) decision of Substantially Equivalent on August 26, 1997, 71 days after the submission was received.
What is the product code of K972231?
The FDA product code is KTN – System, Test, Infectious Mononucleosis, a Class II (moderate risk) device regulated under 21 CFR 866.5640.