Cmv-Complement Fixation Antigen and Negative Contr
FDA 510(k) K852929 · Microbix Biosystems, Inc.
510(k) numberK852929
Submission
- Device name
- Cmv-Complement Fixation Antigen and Negative Contr
- Applicant
- Microbix Biosystems, Inc.
Canada, CA - Received
- July 9, 1985
- Decision date
- November 12, 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 |
|---|---|---|
| K894262 | Rubella Antigen and Control AntigenGON · Traditional | 10/16/1989SE |
| K894261 | Toxoplasma Gondii-Cf Antigen and Control AntigenGMN · Traditional | 10/16/1989SE |
| K852932 | Measles-Complement Fix Antigen & Negative CLTGRF · Traditional | 11/12/1985SE |
| K852931 | Herpes Hominus I-Comple Fix Antigen & Negative CLTGQO · Traditional | 11/12/1985SE |
| K852930 | Varicella-Zoster-Comple Fix Antigen and Neg ControGQX · Traditional | 11/12/1985SE |
| K852933 | Mycoplasma SPP Serological ReagentsGSB · Traditional | 08/01/1985SE |
Questions and answers
When was Cmv-Complement Fixation Antigen and Negative Contr cleared by the FDA?
Cmv-Complement Fixation Antigen and Negative Contr (K852929) received a 510(k) decision of Substantially Equivalent on November 12, 1985, 126 days after the submission was received.
What is the product code of K852929?
The FDA product code is GQI – Antiserum, Cf, Cytomegalovirus, a Class II (moderate risk) device regulated under 21 CFR 866.3175.