Phadeback G.C. Positive Controls
FDA 510(k) K833307 · Pharmacia, Inc.
510(k) numberK833307
Submission
- Device name
- Phadeback G.C. Positive Controls
- Applicant
- Pharmacia, Inc.
Mchenry, IL, US - Received
- September 23, 1983
- Decision date
- December 27, 1983
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- JSX – Kit, Identification, Neisseria Gonorrhoeae
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 866.2660
- Specialty
- Microbiology
Other 510(k)s with product code JSX
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K960759 | Gonopox Test KitJSX · Traditional | Medtex Laboratories, Inc. | 09/18/1996SE |
| K923566 | Nizyme Test KitJSX · Traditional | Remel Co. | 11/02/1992SE |
| K913456 | Visi-NeisseriaJSX · Traditional | Kev Connecticut Diagnostics, Inc. | 10/11/1991SE |
| K880511 | Xact NeisseriaJSX · Traditional | Austin Biological Laboratories | 08/25/1988SE |
| K881501 | Modified Ids Rapid NH SystemJSX · Traditional | Innovative Diagnostic Systems, Inc. | 05/18/1988SE |
| K870117 | Neisseria/Branhamella Differential TestJSX · Traditional | Pro-Lab, Inc. | 03/20/1987SE |
| K853544 | Quad Ferm +JSX · Traditional | Analytical Products, Inc. | 09/05/1985SE |
| K852998 | Neisseria - Kwik PlusJSX · Traditional | Micro-Bio-Logics | 07/23/1985SE |
| K852582 | Goni-KitJSX · Traditional | Culture Kits, Inc. | 07/12/1985SE |
| K833180 | Gonochek-IiJSX · Traditional | E-Y Laboratories, Inc. | 11/14/1983SE |
More from E-Y Laboratories, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K974350 | Allergan Immuno Cap M4, M8, K70DHB · Traditional | 02/09/1998SE |
| K972364 | Unicap PhadiatopDHB · Traditional | 09/04/1997SE |
| K972068 | Unicap Specific Ige Feia Assay, Latex Allergen Immunocap K82DHB · Traditional | 07/03/1997SE |
| K970420 | Mastercap Am 5.0/MASTERCAP RM 5.0JQW · Traditional | 06/30/1997SE |
| K964152 | Unicap Total Ige Assay/Pharmacia Total Ige Controls LMHDGC · Traditional | 04/23/1997SE |
| K962274 | Unicap 100DHB · Traditional | 09/12/1996SE |
| K941993 | Pharmacia Cap System Phadiatop FeiaDHB · Traditional | 01/30/1996SE |
| K954337 | Genotropin MixerFMF · Traditional | 11/13/1995SE |
| K951025 | Piston SyringeFMF · Traditional | 10/19/1995SE |
| K952025 | RobocapJQW · Traditional | 07/26/1995SE |
Questions and answers
When was Phadeback G.C. Positive Controls cleared by the FDA?
Phadeback G.C. Positive Controls (K833307) received a 510(k) decision of Substantially Equivalent on December 27, 1983, 95 days after the submission was received.
What is the product code of K833307?
The FDA product code is JSX – Kit, Identification, Neisseria Gonorrhoeae, a Class I (low risk) device regulated under 21 CFR 866.2660.