Phadebact Monoclonal GC Test
FDA 510(k) K850351 · Pharmacia, Inc.
510(k) numberK850351
Submission
- Device name
- Phadebact Monoclonal GC Test
- Applicant
- Pharmacia, Inc.
Piscataway, NJ, US - Received
- January 28, 1985
- Decision date
- March 13, 1985
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- LIC – Antiserum, Coagglutination (Direct) Neisseria Gonorrhoeae
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.3390
- Specialty
- Microbiology
Other 510(k)s with product code LIC
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K921075 | Phadebact Monoclonal GC Test, ModificationLIC · Traditional | Karo Bio Diagnostics AB | 05/22/1992SE |
| K911430 | Ideia(Tm) Chlamydia, ModificationLIC · Traditional | Novo Nordisk Diagnostics, Ltd. | 08/07/1991SE |
| K880076 | G-MarkLIC · Traditional | Bainbridge Laboratories, Inc. | 07/01/1988SE |
| K874078 | Meritec(Tm)-GcLIC · Traditional | Meridian Diagnostics, Inc. | 12/09/1987SE |
| K871105 | The Gonogen II Test Kit for Neisseria GonorrhoeaeLIC · Traditional | New Horizons Diagnostics Co. | 05/13/1987SE |
| K851650 | Phadebact Monoclonal GC Omni TestLIC · Traditional | Pharmacia, Inc. | 07/12/1985SE |
| K821362 | Improved Gono GenLIC · Traditional | New Horizons Diagnostics Co. | 08/04/1982SE |
| K820007 | Neisseria Gonorrhoeae TestLIC · Traditional | New Horizons Diagnostics Co. | 01/29/1982SE |
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Questions and answers
When was Phadebact Monoclonal GC Test cleared by the FDA?
Phadebact Monoclonal GC Test (K850351) received a 510(k) decision of Substantially Equivalent on March 13, 1985, 44 days after the submission was received.
What is the product code of K850351?
The FDA product code is LIC – Antiserum, Coagglutination (Direct) Neisseria Gonorrhoeae, a Class II (moderate risk) device regulated under 21 CFR 866.3390.