Monocol/Lex-Im Test
FDA 510(k) K972457 · Immunostics Inc.,
510(k) numberK972457
Submission
- Device name
- Monocol/Lex-Im Test
- Applicant
- Immunostics Inc.,
Ocean, NJ, US - Received
- July 1, 1997
- Decision date
- December 1, 1997
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement 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 |
| 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 |
| K961550 | Qualitrol Mono Control Serum SetKTN · Traditional | Consolidated Technologies, Inc. | 09/24/1996SE |
More from Consolidated Technologies, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K221817 | ALFIS Vitamin D, ALFIS-3 AnalyzerMRG · Traditional | 09/22/2023SE |
| K182298 | hemochroma PLUS SystemGKR · Traditional | 11/16/2018SE |
| K163465 | hemochroma PLUS SystemGKR · Traditional | 09/08/2017SE |
| K163225 | AFIAS iFOB with AFIAS-50OOX · Traditional | 08/08/2017SE |
| K171484 | hema-screen SPECIFIC GoldKHE · Special | 06/14/2017SE |
| K163554 | hema-screen ER XCEL Enhanced Readability Fecal Occult Blood TestKHE · Special | 01/17/2017SE |
| K102664 | Hema Screen ErKHE · Special | 01/28/2011SE |
| K060463 | Hema Screen Specific IfobtKHE · Traditional | 06/06/2006SE |
| K041728 | HCG Detector Combi, HCG Detector Stix, HCG Detector CassetteJHI · Traditional | 08/11/2004SE |
| K031490 | RubellacolLQN · Traditional | 07/16/2003SE |
Questions and answers
When was Monocol/Lex-Im Test cleared by the FDA?
Monocol/Lex-Im Test (K972457) received a 510(k) decision of Substantially Equivalent on December 1, 1997, 153 days after the submission was received.
What is the product code of K972457?
The FDA product code is KTN – System, Test, Infectious Mononucleosis, a Class II (moderate risk) device regulated under 21 CFR 866.5640.