Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus
FDA 510(k) K952254 · Pyramid Biological Corp.
510(k) numberK952254
Submission
- Device name
- Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus
- Applicant
- Pyramid Biological Corp.
Van Nuys, CA, US - Received
- May 15, 1995
- Decision date
- November 16, 1995
- 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 |
|---|---|---|---|
| K951800 | CMV Igg Human Serum ControlsGQI · Traditional | Pyramid Biological Corp. | 11/16/1995SE |
| K942171 | CMV Early Antigen TestGQI · Traditional | Neogenex | 06/30/1994SE |
| 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 |
More from Cytotech, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K964675 | H.Pylori ControlsLYR · Traditional | 01/27/1997SE |
| K962399 | Hepatitis Negative ControlMJY · Traditional | 08/02/1996SE |
| K961317 | Syphilis Igm Human Serum ControlsLIP · Traditional | 06/24/1996SE |
| K960493 | Syphilis Igg Human Serum ControlsLIP · Traditional | 06/17/1996SE |
| K954515 | Enzyme Linked Immunoabsorbent Assay, RubellaGOM · Traditional | 12/20/1995SE |
| K953826 | Enzyme Linked Umminoabsorbent Assay, RubellaGOM · Traditional | 12/14/1995SE |
| K952818 | Enzyme Linked Immunoabsorbent Assay, Toxoplasma GondiiGMM · Traditional | 11/20/1995SE |
| K951800 | CMV Igg Human Serum ControlsGQI · Traditional | 11/16/1995SE |
| K944515 | Serum Protein ControlsJJX · Traditional | 11/17/1994SE |
| K933218 | Refractometric, Total ProteinJJX · Traditional | 02/17/1994SE |
Questions and answers
When was Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus cleared by the FDA?
Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus (K952254) received a 510(k) decision of Substantially Equivalent on November 16, 1995, 185 days after the submission was received.
What is the product code of K952254?
The FDA product code is GQI – Antiserum, Cf, Cytomegalovirus, a Class II (moderate risk) device regulated under 21 CFR 866.3175.