Colorgene DNA Hybridization Test CMV Confirmation
FDA 510(k) K872576 · Enzo Biochem, Inc.
510(k) numberK872576
Submission
- Device name
- Colorgene DNA Hybridization Test CMV Confirmation
- Applicant
- Enzo Biochem, Inc.
New York, NY, US - Received
- June 30, 1987
- Decision date
- December 4, 1987
- 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 |
| 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 |
|---|---|---|
| K880604 | Colorgene HSV DNA Hybridization TestGQN · Traditional | 08/03/1988SE |
| K881907 | Hemagel(Tm) Test for Fecal Occult BloodKHE · Traditional | 07/08/1988SE |
| K875367 | Colorgene Fluorescent DNA Hybridization Test / CMVGQM · Traditional | 03/28/1988SE |
| K870733 | Colorgene DNA Hybridization Test for HSV Confirma.GQN · Traditional | 05/26/1987SE |
Questions and answers
When was Colorgene DNA Hybridization Test CMV Confirmation cleared by the FDA?
Colorgene DNA Hybridization Test CMV Confirmation (K872576) received a 510(k) decision of Substantially Equivalent on December 4, 1987, 157 days after the submission was received.
What is the product code of K872576?
The FDA product code is GQH – Antigen, Cf (Including Cf Control), Cytomegalovirus, a Class II (moderate risk) device regulated under 21 CFR 866.3175.