The Cmv-Igm Test
FDA 510(k) K860450 · Microbiological Research Corp.
510(k) numberK860450
Submission
- Device name
- The Cmv-Igm Test
- Applicant
- Microbiological Research Corp.
Bountiful, UT, US - Received
- February 4, 1986
- Decision date
- May 13, 1986
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- LKQ – Antibody Igm,If, Cytomegalovirus Virus
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.3175
- Specialty
- Microbiology
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| K913080 | Opus(R) Anti Cmv-MLKQ · Traditional | Pb Diagnostics, Inc. | 10/28/1991SE |
| K900743 | Cmv-Igm Ifa Test SystemLKQ · Traditional | Zeus Scientific, Inc. | 04/26/1990SE |
| K893465 | CMV Igm Antibody Test (Indirect Fluorescent Test)LKQ · Traditional | Immuno Concepts, Inc. | 07/25/1989SE |
| K893466 | CMV Igm Antibody Test (Indirect Enzyme Test)LKQ · Traditional | Immuno Concepts, Inc. | 07/14/1989SE |
| K872881 | Abbott Cmv-M Eia KitLKQ · Traditional | Abbott Laboratories | 05/13/1988SE |
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| K861121 | The Golden Quad Test (Ebv)GNP · Traditional | 02/02/1987SE |
| K861120 | The Golden Quad Test (HSV)GQO · Traditional | 02/02/1987SE |
| K843138 | CMV TestLIN · Traditional | 01/29/1985SE |
| 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 The Cmv-Igm Test cleared by the FDA?
The Cmv-Igm Test (K860450) received a 510(k) decision of Substantially Equivalent on May 13, 1986, 98 days after the submission was received.
What is the product code of K860450?
The FDA product code is LKQ – Antibody Igm,If, Cytomegalovirus Virus, a Class II (moderate risk) device regulated under 21 CFR 866.3175.