Cholerascreen
FDA 510(k) K922432 · New Horizons Diagnostics Co.
510(k) numberK922432
Submission
- Device name
- Cholerascreen
- Applicant
- New Horizons Diagnostics Co.
Columbia, MD, US - Received
- May 22, 1992
- Decision date
- December 7, 1992
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- GSQ – Antiserum, Vibrio Cholerae, All Varieties
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.3930
- Specialty
- Microbiology
Other 510(k)s with product code GSQ
More from New Horizons Diagnostics Co.
| 510(k) | Device | Decision |
|---|---|---|
| K932622 | Cholera Smart(Tm)GSQ · Traditional | 06/27/1995SE |
| K925190 | PyloriscreenLYR · Traditional | 03/23/1993SE |
| K874761 | Rapid Colorimetric Direct Strep a TestGTZ · Traditional | 02/19/1988SE |
| K871226 | Syphilis Serological ReagentsGMQ · Traditional | 05/28/1987SE |
| K871105 | The Gonogen II Test Kit for Neisseria GonorrhoeaeLIC · Traditional | 05/13/1987SE |
| K862195 | Rapid Bacteriuria Screen (RBS)JXA · Traditional | 06/30/1986SE |
| K851132 | Latex Agglutination TestGTZ · Traditional | 07/05/1985SE |
| K821362 | Improved Gono GenLIC · Traditional | 08/04/1982SE |
| K820007 | Neisseria Gonorrhoeae TestLIC · Traditional | 01/29/1982SE |
Questions and answers
When was Cholerascreen cleared by the FDA?
Cholerascreen (K922432) received a 510(k) decision of Substantially Equivalent on December 7, 1992, 199 days after the submission was received.
What is the product code of K922432?
The FDA product code is GSQ – Antiserum, Vibrio Cholerae, All Varieties, a Class II (moderate risk) device regulated under 21 CFR 866.3930.