Product Code: JSX
FDA class 1
21 CFR 866.2660
Kit, Identification, Neisseria Gonorrhoeae
Microbiology
Kit, Identification, Neisseria Gonorrhoeae is a diagnostic microbiology kit used to identify Neisseria gonorrhoeae, the causative agent of gonorrhea, from clinical specimens such as urogenital swabs. It is classified as FDA Class 1, posing the lowest risk and subject to general controls only. The product code is JSX, regulated under 21 CFR 866.2660, and falls within the Microbiology medical specialty.
510(k)s
16
FEI Numbers
8
Registration Numbers
8
Unique Applicants
16
Years Active
18
Basic Information
- Product Code
- JSX
- Device Class
- FDA class 1
- Regulation Number
- 866.2660
- Medical Specialty
- Microbiology
- Review Panel
- MI
- Submission Type
- 4
Device Characteristics
✗
GMP Exempt
✗
Implant
✗
Life Sustain/Support
✗
Third Party
—
Summary Malfunction Reporting
510(k) Clearance History
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Related 510(k) Clearances
This FDA classification is associated with 16 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K960759 | GONOPOX TEST KIT | Sep 18, 1996 | Substantially Equivalent | MEDTEX LABORATORIES, INC. |
| K923566 | NIZYME TEST KIT | Nov 02, 1992 | Substantially Equivalent | REMEL CO. |
| K913456 | VISI-NEISSERIA | Oct 11, 1991 | Substantially Equivalent | KEV CONNECTICUT DIAGNOSTICS, INC. |
| K880511 | XACT NEISSERIA | Aug 25, 1988 | Substantially Equivalent | AUSTIN BIOLOGICAL LABORATORIES |
| K881501 | MODIFIED IDS RAPID NH SYSTEM | May 18, 1988 | Substantially Equivalent | INNOVATIVE DIAGNOSTIC SYSTEMS, INC. |
| K870117 | NEISSERIA/BRANHAMELLA DIFFERENTIAL TEST | Mar 20, 1987 | Substantially Equivalent | PRO-LAB, INC. |
| K853544 | QUAD FERM + | Sep 05, 1985 | Substantially Equivalent | ANALYTICAL PRODUCTS, INC. |
| K852998 | NEISSERIA - KWIK PLUS | Jul 23, 1985 | Substantially Equivalent | MICRO-BIO-LOGICS |
| K852582 | GONI-KIT | Jul 12, 1985 | Substantially Equivalent | CULTURE KITS, INC. |
| K833307 | PHADEBACK G.C. POSITIVE CONTROLS | Dec 27, 1983 | Substantially Equivalent | PHARMACIA, INC. |
| K833180 | GONOCHEK-II | Nov 14, 1983 | Substantially Equivalent | E-Y LABORATORIES, INC. |
| K830364 | NEISSERIA IDENTIFICATION DISCS | Mar 08, 1983 | Substantially Equivalent | OXOID U.S.A., INC. |
| K812048 | IDS RAPIDS NH SYSTEMS | Aug 18, 1981 | Substantially Equivalent | CARR-SCARBOROUGH MICROBIOLOGICALS, INC. |
| K811412 | NEISSERIA-KWIK | Jun 16, 1981 | Substantially Equivalent | WINDSOR LABORATORIES, INC. |
| K782013 | GONO-CELL | Apr 23, 1979 | Substantially Equivalent | ABBOTT LABORATORIES |
| K781108 | MICROCULT-GC CULTURE TEST | Aug 31, 1978 | Substantially Equivalent | MILES LABORATORIES, INC. |
FEI Numbers
This FDA classification entry is associated with 8 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 8 registration numbers. Click on an entry to view related FDA registrations.