Anti-Cytomegalovirus Kit
FDA 510(k) K842661 · Amico Lab, Inc.
510(k) numberK842661
Submission
- Device name
- Anti-Cytomegalovirus Kit
- Applicant
- Amico Lab, Inc.
- Received
- July 10, 1984
- Decision date
- December 6, 1985
- 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 |
| K862705 | Cytomegalovirus Igg Eia Test KitGQI · Traditional | Labsystems, Inc. | 10/01/1986SE |
| K853989 | Cor Dot CMVGQI · Traditional | Cordis Corp. | 06/13/1986SE |
More from Cordis Corp.
| 510(k) | Device | Decision |
|---|---|---|
| K842662 | Anti-Epstein-Barr Virus KitGNP · Traditional | 12/12/1985SE |
| K842663 | Anti-Herpes Simplex Virus Type 1 or 2GQO · Traditional | 12/06/1985SE |
| K842531 | Amizyme-Hsv Types 1 & 2 Test KitsGQO · Traditional | 12/06/1985SE |
| K842530 | Amizyme-Ebv Test KitGNP · Traditional | 12/06/1985SE |
| K842529 | Amizyme-Cmv KitGQI · Traditional | 12/06/1985SE |
| K842660 | Anti-Schistosoma Species KitGNH · Traditional | 10/30/1984SE |
| K842658 | Anti-Chlamydia Trachomatis KitLJP · Traditional | 10/01/1984SE |
| K842525 | Amizyme-C Trachomatis Test KitLJP · Traditional | 10/01/1984SE |
| K842533 | Amizyme-Andna Test KitLJM · Traditional | 09/20/1984SE |
| K842532 | Amizyme-Ana Test KitLJM · Traditional | 09/20/1984SE |
Questions and answers
When was Anti-Cytomegalovirus Kit cleared by the FDA?
Anti-Cytomegalovirus Kit (K842661) received a 510(k) decision of Substantially Equivalent on December 6, 1985, 514 days after the submission was received.
What is the product code of K842661?
The FDA product code is GQI – Antiserum, Cf, Cytomegalovirus, a Class II (moderate risk) device regulated under 21 CFR 866.3175.