CMV Bio-Bead Screen Kit
FDA 510(k) K791612 · Litton Bionetics
510(k) numberK791612
Submission
- Device name
- CMV Bio-Bead Screen Kit
- Applicant
- Litton Bionetics
Mchenry, IL, US - Received
- August 21, 1979
- Decision date
- November 13, 1979
- 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 |
|---|---|---|
| K840417 | Ebna Acif KitLLM · Traditional | 12/27/1984SE |
| K834443 | Rotavirus Bio-Enzabead Screen KitLIQ · Traditional | 03/16/1984SE |
| K831343 | CMV RQ Bio-Enzabead KitLFZ · Traditional | 08/08/1983SE |
| K822985 | Ebv-M KitJRY · Traditional | 12/03/1982SE |
| K821804 | Rubella RQ Bio-Enzabead KitLFX · Traditional | 09/14/1982SE |
| K801722 | CMV Bio-Bead Titration KitGQH · Traditional | 09/16/1980SE |
| K801721 | HSV Bio-Bead Titration KitGQN · Traditional | 09/16/1980SE |
| K801720 | Toxo Bio-Bead Titration KitGLZ · Traditional | 09/16/1980SE |
| K800789 | Rubella Bio-Bead Titration KitGOL · Traditional | 06/30/1980SE |
| K791618 | Torch Bio-Bead Screen KitGLZ · Traditional | 11/13/1979SE |
Questions and answers
When was CMV Bio-Bead Screen Kit cleared by the FDA?
CMV Bio-Bead Screen Kit (K791612) received a 510(k) decision of Substantially Equivalent on November 13, 1979, 84 days after the submission was received.
What is the product code of K791612?
The FDA product code is GQH – Antigen, Cf (Including Cf Control), Cytomegalovirus, a Class II (moderate risk) device regulated under 21 CFR 866.3175.