510(k) K821362
- Device
- IMPROVED GONO GEN
- Applicant
- NEW HORIZONS DIAGNOSTICS CO.
- 510(k) number
- K821362
- Product code
- LIC
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1982-08-04
- Date received
- 1982-05-07
- Regulation
- 866.3390
- Classification name
- Antiserum, Coagglutination (direct) Neisseria Gonorrhoeae
- Medical specialty
- Microbiology
- Review panel
- Microbiology
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Address
- MD US
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code LIC #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K921075 | PHADEBACT MONOCLONAL GC TEST, MODIFICATION | Karo Bio Diagnostics AB | 1992-05-22 |
| K911430 | IDEIA(TM) CHLAMYDIA, MODIFICATION | Novo Nordisk Diagnostics, Ltd. | 1991-08-07 |
| K880076 | G-MARK | Bainbridge Laboratories, Inc. | 1988-07-01 |
| K874078 | MERITEC(TM)-GC | Meridian Diagnostics, Inc. | 1987-12-09 |
| K871105 | THE GONOGEN II TEST KIT FOR NEISSERIA GONORRHOEAE | New Horizons Diagnostics Co. | 1987-05-13 |
| K851650 | PHADEBACT MONOCLONAL GC OMNI TEST | Pharmacia, Inc. | 1985-07-12 |
| K850351 | PHADEBACT MONOCLONAL GC TEST | Pharmacia, Inc. | 1985-03-13 |
| K820007 | NEISSERIA GONORRHOEAE TEST | New Horizons Diagnostics Co. | 1982-01-29 |
Legacy Summary#
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FDA Review#
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