Bartels Cinakit CMV Antigenemia
FDA 510(k) K982311 · Intracel Corp.
510(k) numberK982311
Submission
- Device name
- Bartels Cinakit CMV Antigenemia
- Applicant
- Intracel Corp.
Rockville, MD, US - Received
- July 1, 1998
- Decision date
- December 14, 1998
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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 |
|---|---|---|---|
| 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 |
| K864565 | Monabrite Cytomegalovirus (CMV) Ifa KitGQH · Traditional | Serono Diagnostics, Inc. | 02/19/1987SE |
More from Serono Diagnostics, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K003204 | Bartels Viral Respiratory Screening and Identification KitGNW · Special | 11/07/2000SE |
| K991074 | Bartels Legionella Urinary Antigen Elisa TestMJH · Traditional | 12/21/1999SE |
| K990664 | Prima System - Old, Bartels Elisa - NewLLH · Special | 03/31/1999SE |
| K933878 | Zymmune(Tm) CD4/CD8 Cell Monitoring KitGKZ · Traditional | 11/14/1995SE |
Questions and answers
When was Bartels Cinakit CMV Antigenemia cleared by the FDA?
Bartels Cinakit CMV Antigenemia (K982311) received a 510(k) decision of Substantially Equivalent on December 14, 1998, 166 days after the submission was received.
What is the product code of K982311?
The FDA product code is GQH – Antigen, Cf (Including Cf Control), Cytomegalovirus, a Class II (moderate risk) device regulated under 21 CFR 866.3175.