CMV Test
FDA 510(k) K843138 · Microbiological Research Corp.
510(k) numberK843138
Submission
- Device name
- CMV Test
- Applicant
- Microbiological Research Corp.
Bountiful, UT, US - Received
- August 9, 1984
- Decision date
- January 29, 1985
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- LIN – Antisera, Conjugated Fluorescent, Cytomegalovirus
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.3175
- Specialty
- Microbiology
Other 510(k)s with product code LIN
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K081164 | D3 Dfa Cytomegalovirus Immediate Early Antigen Identification KitLIN · Traditional | Diagnostic Hybrids, Inc. | 06/13/2008SE |
| K983762 | Nuclisens CMV PP67LIN · Traditional | Organon Teknika Corp. | 09/15/1999SE |
| K991650 | CMV Brite Turbo KitLIN · Special | Biotest Diagnostics Corp. | 07/12/1999SE |
| K951821 | Cytomegalovirus Direct Immunofluorescence AssayLIN · Traditional | Light Diagnostics | 06/07/1996SE |
| K951550 | CMV Brite Antigenemia Test KitLIN · Traditional | Biotest Diagnostics Corp. | 01/30/1996SE |
| K934798 | Pathodx CytomegalovirusLIN · Traditional | Diagnostic Products Corp. | 03/25/1994SE |
| K921616 | Cmv-Vue(Tm) CMV Antigen Detection KitLIN · Traditional | Incstar Corp. | 08/11/1992SN |
| K912592 | Cmv-Ea Mab TestLIN · Traditional | Gull Laboratories, Inc. | 12/04/1991SE |
| K905257 | Opus CMV Test SystemLIN · Traditional | Pb Diagnostic Systems, Inc. | 04/17/1991SE |
| K904036 | Bartels Cytomegalovirus Immed. Early AntigenLIN · Traditional | Baxter Healthcare Corp | 10/16/1990SE |
More from Baxter Healthcare Corp
| 510(k) | Device | Decision |
|---|---|---|
| K883011 | MRI Neo-Tryp Trypsin RiaJNO · Traditional | 04/26/1989SE |
| K861123 | The Golden Quad Test (CMV)GQI · Traditional | 02/02/1987SE |
| K861122 | The Golden Quad Test (Toxo)LJK · Traditional | 02/02/1987SE |
| K861121 | The Golden Quad Test (Ebv)GNP · Traditional | 02/02/1987SE |
| K861120 | The Golden Quad Test (HSV)GQO · Traditional | 02/02/1987SE |
| K860450 | The Cmv-Igm TestLKQ · Traditional | 05/13/1986SE |
| K821018 | Antihuman Igg Globulin Fitc LabeledDEW · Traditional | 04/29/1982SE |
| K821019 | Phosphate Buffered Clycerol Mounting FluLEB · Traditional | 04/26/1982SE |
| K803175 | Rubella Virus Serological ReagentsLFX · Traditional | 01/29/1981SE |
| K803134 | Toxoplasma Gondii Serological ReagentsGLZ · Traditional | 01/29/1981SE |
Questions and answers
When was CMV Test cleared by the FDA?
CMV Test (K843138) received a 510(k) decision of Substantially Equivalent on January 29, 1985, 173 days after the submission was received.
What is the product code of K843138?
The FDA product code is LIN – Antisera, Conjugated Fluorescent, Cytomegalovirus, a Class II (moderate risk) device regulated under 21 CFR 866.3175.