Cytomegalovirus
FDA 510(k) K843657 · Institute Virion , Ltd.
510(k) numberK843657
Submission
- Device name
- Cytomegalovirus
- Applicant
- Institute Virion , Ltd.
Walker, MI, US - Received
- September 17, 1984
- Decision date
- September 26, 1985
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- GQH – Antigen, Cf (Including Cf Control), Cytomegalovirus
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.3175
- Specialty
- Microbiology
Other 510(k)s with product code GQH
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K982311 | Bartels Cinakit CMV AntigenemiaGQH · Traditional | Intracel Corp. | 12/14/1998SE |
| K964875 | CMV Antigen Control SlidesGQH · Traditional | Viral Antigens, Inc. | 03/18/1997SE |
| K935809 | Cytomegalovirus Indirect Immunofluorescence AssayGQH · Traditional | Light Diagnostics | 05/05/1994SE |
| K882835 | Indirect Fluorescent Assay for (HCMV)GQH · Traditional | Stellar Bio Systems, Inc. | 12/05/1988SE |
| K882024 | Fitc Murine Monoclonal Anti-Cmv IggGQH · Traditional | Whittaker Bioproducts, Inc. | 08/03/1988SE |
| K881932 | Ortho* Cytomegalovirus Identification ReagentGQH · Traditional | Ortho Diagnostic Systems, Inc. | 08/01/1988SE |
| K880679 | Bion Cmv-G Test SystemGQH · Traditional | Bion Ent., Ltd. | 06/03/1988SE |
| K880290 | Microtrak CMV Culture Confirmation TestGQH · Traditional | Syva Co. | 04/19/1988SE |
| K872576 | Colorgene DNA Hybridization Test CMV ConfirmationGQH · Traditional | Enzo Biochem, Inc. | 12/04/1987SE |
| K873114 | Cytomegalovirus Control SlidesGQH · Traditional | Medical Diagnostic Technologies, Inc. | 09/25/1987SE |
More from Medical Diagnostic Technologies, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K862814 | Complement-Fixation Test for Campylobacter JejuniLQP · Traditional | 09/30/1986SE |
| K843676 | Varicella/Zoster VirusGQW · Traditional | 09/26/1985SE |
| K843673 | Respiratory Syncytial VirusGQG · Traditional | 09/26/1985SE |
| K843667 | Parainfluenza 3GQS · Traditional | 09/26/1985SE |
| K843665 | Parainfluenza 1GQS · Traditional | 09/26/1985SE |
| K843662 | Measles Virus RubeolaGRJ · Traditional | 09/26/1985SE |
| K843660 | In Fluenza B VirusGNX · Traditional | 09/26/1985SE |
| K843659 | Influenza A2 VirusGNX · Traditional | 09/26/1985SE |
| K843658 | H. Simplex VirusGQN · Traditional | 09/26/1985SE |
| K843649 | AdenovirusGOD · Traditional | 09/26/1985SE |
Questions and answers
When was Cytomegalovirus cleared by the FDA?
Cytomegalovirus (K843657) received a 510(k) decision of Substantially Equivalent on September 26, 1985, 374 days after the submission was received.
What is the product code of K843657?
The FDA product code is GQH – Antigen, Cf (Including Cf Control), Cytomegalovirus, a Class II (moderate risk) device regulated under 21 CFR 866.3175.