Cytomegalovirus Igg Eia Test Kit
FDA 510(k) K862705 · Labsystems, Inc.
510(k) numberK862705
Submission
- Device name
- Cytomegalovirus Igg Eia Test Kit
- Applicant
- Labsystems, Inc.
Chicago, IL, US - Received
- July 16, 1986
- Decision date
- October 1, 1986
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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 |
| 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 |
| 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 |
|---|---|---|
| K923365 | Tilt/Reduced Shear Semi-Recline Seating SystemITI · Traditional | 03/24/1993SE |
| K896474 | Resubmitted Fecatwin Sensitive - Feca-EiaKHE · Traditional | 01/25/1990SE |
| K890154 | Modified Labysystems' Toxoplasma Gondii Igg EiaLGD · Traditional | 02/07/1989SE |
| K890091 | Modified Labsystems' Rubella Igg Eia Test KitLFX · Traditional | 02/03/1989SE |
| K881243 | Rubella Igg - Eia Test Kit Number 61 07 201LFX · Traditional | 04/04/1988SE |
| K873780 | Modification Rubella Igm Eia Test KitLFX · Traditional | 10/15/1987SE |
| K873583 | Auto-EiaJJQ · Traditional | 09/22/1987SE |
| K872252 | Modified Toxoplasma Gondii Igg Eia Test KitLGD · Traditional | 07/01/1987SE |
| K862431 | Rubella Igm Eia Test KitLFX · Traditional | 08/08/1986SE |
| K862216 | Toxoplasma Gondii Igg Eia Test Kit (Amendment)LGD · Traditional | 06/30/1986SE |
Questions and answers
When was Cytomegalovirus Igg Eia Test Kit cleared by the FDA?
Cytomegalovirus Igg Eia Test Kit (K862705) received a 510(k) decision of Substantially Equivalent on October 1, 1986, 77 days after the submission was received.
What is the product code of K862705?
The FDA product code is GQI – Antiserum, Cf, Cytomegalovirus, a Class II (moderate risk) device regulated under 21 CFR 866.3175.