CMV Early Antigen Test
FDA 510(k) K942171 · Neogenex
510(k) numberK942171
Submission
- Device name
- CMV Early Antigen Test
- Applicant
- Neogenex
Everett, WA, US - Received
- May 5, 1994
- Decision date
- June 30, 1994
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- GQI – Antiserum, Cf, Cytomegalovirus
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.3175
- Specialty
- Microbiology
Other 510(k)s with product code GQI
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K952254 | Enzyme Linked Immunoabsorbent Assay, CytomegalovirusGQI · Traditional | Pyramid Biological Corp. | 11/16/1995SE |
| K951800 | CMV Igg Human Serum ControlsGQI · Traditional | Pyramid Biological Corp. | 11/16/1995SE |
| K883102 | Virgo (R) Cmv-Igg ElisaGQI · Traditional | Electro-Nucleonics, Inc. | 02/08/1989SE |
| K875159 | Detectadot System 2000 CMV Igg TestGQI · Traditional | Gull Laboratories, Inc. | 05/06/1988SE |
| K863488 | Enzygnost Anti-Cmv Igg TestGQI · Traditional | Behring Diagnostics, Inc. | 07/20/1987SE |
| K864420 | CMV MicroassayGQI · Traditional | Diamedix Corp. | 02/02/1987SE |
| K861123 | The Golden Quad Test (CMV)GQI · Traditional | Microbiological Research Corp. | 02/02/1987SE |
| K862705 | Cytomegalovirus Igg Eia Test KitGQI · Traditional | Labsystems, Inc. | 10/01/1986SE |
| K853989 | Cor Dot CMVGQI · Traditional | Cordis Corp. | 06/13/1986SE |
| K860493 | Cytotech CMV Igg EiaGQI · Traditional | Cytotech, Inc. | 05/20/1986SE |
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| K943891 | RD Culture CellKIR · Traditional | 11/28/1994SE |
| K943890 | WI38 Cell CultureKIR · Traditional | 11/28/1994SE |
| K943889 | Vero Cell CultureKIR · Traditional | 11/28/1994SE |
| K943888 | MDCK Cell CultureKIR · Traditional | 11/28/1994SE |
| K943887 | Human Newborn Foreskin Cell CultureKIR · Traditional | 11/28/1994SE |
| K943886 | BGM Cell CultureKIR · Traditional | 11/28/1994SE |
| K943885 | Primary Rabbit Kidney Cell CultureKIR · Traditional | 11/28/1994SE |
| K943884 | Primary Monkey Kidney Cell CultureKIR · Traditional | 11/28/1994SE |
Questions and answers
When was CMV Early Antigen Test cleared by the FDA?
CMV Early Antigen Test (K942171) received a 510(k) decision of Substantially Equivalent on June 30, 1994, 56 days after the submission was received.
What is the product code of K942171?
The FDA product code is GQI – Antiserum, Cf, Cytomegalovirus, a Class II (moderate risk) device regulated under 21 CFR 866.3175.