Genzyme Diagnostics Contrast Mono
FDA 510(k) K963425 · Genzyme Diagnostics
510(k) numberK963425
Submission
- Device name
- Genzyme Diagnostics Contrast Mono
- Applicant
- Genzyme Diagnostics
San Carlos, CA, US - Received
- August 30, 1996
- Decision date
- February 25, 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 |
| K972231 | Osom Mono Test 143KTN · Traditional | Wyntek Diagnostics, Inc. | 08/26/1997SE |
| 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 |
|---|---|---|
| K043385 | Osom HCG Combo TestJHI · Traditional | 04/12/2005SE |
| K983399 | Giardia/Cryptosporidium Combo Rapid AssayMHI · Traditional | 01/11/1999SE |
| K964156 | Contrast Strip HCGJHI · Traditional | 11/25/1996SE |
| K964155 | Contrast HCG Urine/Serum Test and Rapid HCG Urine/Serum TestJHI · Traditional | 11/25/1996SE |
Questions and answers
When was Genzyme Diagnostics Contrast Mono cleared by the FDA?
Genzyme Diagnostics Contrast Mono (K963425) received a 510(k) decision of Substantially Equivalent on February 25, 1997, 179 days after the submission was received.
What is the product code of K963425?
The FDA product code is KTN – System, Test, Infectious Mononucleosis, a Class II (moderate risk) device regulated under 21 CFR 866.5640.