Indirect Fluorescent Assay for (HCMV)
FDA 510(k) K882835 · Stellar Bio Systems, Inc.
510(k) numberK882835
Submission
- Device name
- Indirect Fluorescent Assay for (HCMV)
- Applicant
- Stellar Bio Systems, Inc.
Columbia, MD, US - Received
- July 8, 1988
- Decision date
- December 5, 1988
- 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 |
| 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 |
|---|---|---|
| K992587 | Epstein-Barr Virus Early Antigen (Ebv-Ea) Igg Ifa Test SystemLSE · Traditional | 12/22/1999SE |
| K990916 | Indirect Fluorescence Assay for Anti-Native DNA Igg AntibodyKTL · Traditional | 04/21/1999SE |
| K990915 | Indirect Fluorescence Assay for Anti-Nuclear Antibodies Igg AntibodyDHN · Traditional | 04/21/1999SE |
| K914953 | Ifa for Chlamydia Trachomatis Igg AntibodyLKI · Traditional | 02/19/1992SE |
| K905608 | Indirect Fluorescent Assay for Herpes Simplex 1GQL · Traditional | 11/07/1991SE |
| K900974 | Indirect Fluorescent Assay for (Ebv-Vca) Igg Anti.JRY · Traditional | 04/16/1990SE |
Questions and answers
When was Indirect Fluorescent Assay for (HCMV) cleared by the FDA?
Indirect Fluorescent Assay for (HCMV) (K882835) received a 510(k) decision of Substantially Equivalent on December 5, 1988, 150 days after the submission was received.
What is the product code of K882835?
The FDA product code is GQH – Antigen, Cf (Including Cf Control), Cytomegalovirus, a Class II (moderate risk) device regulated under 21 CFR 866.3175.