Enzygnost Anti-Cmv Igg Test
FDA 510(k) K863488 · Behring Diagnostics, Inc.
510(k) numberK863488
Submission
- Device name
- Enzygnost Anti-Cmv Igg Test
- Applicant
- Behring Diagnostics, Inc.
La Jolla, CA, US - Received
- September 9, 1986
- Decision date
- July 20, 1987
- 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 |
| 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 |
|---|---|---|
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| K972840 | N Antiserum to Human TransferrinDDG · Traditional | 10/17/1997SE |
| K973202 | Modification of Opus Ferritin Test SystemDBF · Traditional | 09/12/1997SE |
| K972316 | Opus D-DimerGHH · Traditional | 09/09/1997SE |
| K972116 | Von Willebrand ReagentGGP · Traditional | 07/25/1997SE |
| K972011 | Opus EthanolDIC · Traditional | 07/22/1997SE |
| K971600 | Emit Calibrator B Level 1 (Cutoff)/Emit Calibrator B Level 2 (High)DKB · Traditional | 06/25/1997SE |
| K971596 | Emit II Opiates 300/2000 AssayDJG · Traditional | 06/25/1997SE |
| K964595 | Opus Psa Test SystemLTJ · Traditional | 06/24/1997SE |
Questions and answers
When was Enzygnost Anti-Cmv Igg Test cleared by the FDA?
Enzygnost Anti-Cmv Igg Test (K863488) received a 510(k) decision of Substantially Equivalent on July 20, 1987, 314 days after the submission was received.
What is the product code of K863488?
The FDA product code is GQI – Antiserum, Cf, Cytomegalovirus, a Class II (moderate risk) device regulated under 21 CFR 866.3175.