510(k) K851650
- Device
- Phadebact Monoclonal Gc Omni Test
- Applicant
- PHARMACIA, INC.
- 510(k) number
- K851650
- Product code
- LIC
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1985-07-12
- Date received
- 1985-04-22
- 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#
- Contact
- ALBERT P MAYO
- Address
- 800 Centennial Ave. Piscataway NJ US 08854 08854
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 |
| K850351 | PHADEBACT MONOCLONAL GC TEST | Pharmacia, Inc. | 1985-03-13 |
| K821362 | IMPROVED GONO GEN | New Horizons Diagnostics Co. | 1982-08-04 |
| K820007 | NEISSERIA GONORRHOEAE TEST | New Horizons Diagnostics Co. | 1982-01-29 |