Panels › Microbiology › Product code JSX · Class 1
Kit, Identification, Neisseria Gonorrhoeae
Regulation 866.2660
0510(k)s in 12 months (16 all time)
1recalls in 12 months (1 all time)
0recalls that name a 510(k)
Top companies in JSX
| Company | 510(k)s | Recalls |
|---|---|---|
| Abbott Laboratories | 1 | 0 |
| Analytical Products, Inc. | 1 | 0 |
| Austin Biological Laboratories | 1 | 0 |
| Carr-Scarborough Microbiologicals, Inc. | 1 | 0 |
| Culture Kits, Inc. | 1 | 0 |
| E-Y Laboratories, Inc. | 1 | 0 |
| GET TESTED INTERNATIONAL AB | 0 | 1 |
| Innovative Diagnostic Systems, Inc. | 1 | 0 |
| Kev Connecticut Diagnostics, Inc. | 1 | 0 |
| Medtex Laboratories, Inc. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Sep 18, 1996 | K960759 | GONOPOX TEST KIT Medtex Laboratories, Inc. | JSX |
| Nov 2, 1992 | K923566 | NIZYME TEST KIT Remel Co. | JSX |
| Oct 11, 1991 | K913456 | VISI-NEISSERIA Kev Connecticut Diagnostics, Inc. | JSX |
| Aug 25, 1988 | K880511 | XACT NEISSERIA Austin Biological Laboratories | JSX |
| May 18, 1988 | K881501 | MODIFIED IDS RAPID NH SYSTEM Innovative Diagnostic Systems, Inc. | JSX |
| Mar 20, 1987 | K870117 | NEISSERIA/BRANHAMELLA DIFFERENTIAL TEST Pro-Lab, Inc., CA | JSX |
| Sep 5, 1985 | K853544 | QUAD FERM + Analytical Products, Inc. | JSX |
| Jul 23, 1985 | K852998 | NEISSERIA - KWIK PLUS Micro-Bio-Logics | JSX |
| Jul 12, 1985 | K852582 | GONI-KIT Culture Kits, Inc. | JSX |
| Dec 27, 1983 | K833307 | PHADEBACK G.C. POSITIVE CONTROLS Pharmacia, Inc. | JSX |
| Nov 14, 1983 | K833180 | GONOCHEK-II E-Y Laboratories, Inc. | JSX |
| Mar 8, 1983 | K830364 | NEISSERIA IDENTIFICATION DISCS Oxoid U.S.A., Inc. | JSX |
| Aug 18, 1981 | K812048 | IDS RAPIDS NH SYSTEMS Carr-Scarborough Microbiologicals, Inc. | JSX |
| Jun 16, 1981 | K811412 | NEISSERIA-KWIK Windsor Laboratories, Inc. | JSX |
| Apr 23, 1979 | K782013 | GONO-CELL Abbott Laboratories | JSX |
| Aug 31, 1978 | K781108 | MICROCULT-GC CULTURE TEST Miles Laboratories, Inc. | JSX |
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