CMV Test Kit
FDA 510(k) K801963 · Immuno-Diagnostic Products, Inc.
510(k) numberK801963
Submission
- Device name
- CMV Test Kit
- Applicant
- Immuno-Diagnostic Products, Inc.
Walker, MI, US - Received
- August 19, 1980
- Decision date
- October 23, 1980
- 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 |
|---|---|---|
| K854207 | Ebv(Epstein-Barr Virus) Test KitGNP · Traditional | 04/24/1986SE |
| K811021 | HerpesGQN · Traditional | 11/05/1981SE |
| K811562 | Toxoplasmosis Test KitGLZ · Traditional | 07/16/1981SE |
| K811022 | Ana Test KitDHN · Traditional | 04/23/1981SE |
| K801959 | Fta-Abs TestJWL · Traditional | 10/23/1980SE |
| K801961 | Rf-Ii Test KitDHR · Traditional | 10/10/1980SE |
| K801960 | Anti-Ds/N-Dna Test KitDBL · Traditional | 10/10/1980SE |
Questions and answers
When was CMV Test Kit cleared by the FDA?
CMV Test Kit (K801963) received a 510(k) decision of Substantially Equivalent on October 23, 1980, 65 days after the submission was received.
What is the product code of K801963?
The FDA product code is GQH – Antigen, Cf (Including Cf Control), Cytomegalovirus, a Class II (moderate risk) device regulated under 21 CFR 866.3175.