510(k) K782013
- Device
- Gono-cell
- Applicant
- ABBOTT LABORATORIES
- 510(k) number
- K782013
- Product code
- JSX
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1979-04-23
- Date received
- 1978-12-05
- Regulation
- 866.2660
- Classification name
- Kit, Identification, Neisseria Gonorrhoeae
- Medical specialty
- Microbiology
- Review panel
- Microbiology
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Address
- One Abbott Park Rd. Abbott Park IL US 60064 60064
FDA Registration Numbers#
- 3003750284
- 1924669
- 3026312356
- 2032682
- 3016837106
- 2029372
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code JSX#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K960759 | GONOPOX TEST KIT | Medtex Laboratories, Inc. | 1996-09-18 |
| K923566 | NIZYME TEST KIT | Remel Co. | 1992-11-02 |
| K913456 | VISI-NEISSERIA | Kev Connecticut Diagnostics, Inc. | 1991-10-11 |
| K880511 | XACT NEISSERIA | Austin Biological Laboratories | 1988-08-25 |
| K881501 | MODIFIED IDS RAPID NH SYSTEM | Innovative Diagnostic Systems, Inc. | 1988-05-18 |
| K870117 | NEISSERIA/BRANHAMELLA DIFFERENTIAL TEST | Pro-Lab, Inc. | 1987-03-20 |
| K853544 | QUAD FERM + | Analytical Products, Inc. | 1985-09-05 |
| K852998 | NEISSERIA - KWIK PLUS | Micro-Bio-Logics | 1985-07-23 |
| K852582 | GONI-KIT | Culture Kits, Inc. | 1985-07-12 |
| K833307 | PHADEBACK G.C. POSITIVE CONTROLS | Pharmacia, Inc. | 1983-12-27 |
| K833180 | GONOCHEK-II | E-Y Laboratories, Inc. | 1983-11-14 |
| K830364 | NEISSERIA IDENTIFICATION DISCS | Oxoid U.S.A., Inc. | 1983-03-08 |
| K812048 | IDS RAPIDS NH SYSTEMS | Carr-Scarborough Microbiologicals, Inc. | 1981-08-18 |
| K811412 | NEISSERIA-KWIK | Windsor Laboratories, Inc. | 1981-06-16 |
| K781108 | MICROCULT-GC CULTURE TEST | Miles Laboratories, Inc. | 1978-08-31 |