Neisseria/Branhamella Differential Test
FDA 510(k) K870117 · Pro-Lab, Inc.
510(k) numberK870117
Submission
- Device name
- Neisseria/Branhamella Differential Test
- Applicant
- Pro-Lab, Inc.
Scarborough Ont, CA - Received
- January 12, 1987
- Decision date
- March 20, 1987
- 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 |
| 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 |
| K833307 | Phadeback G.C. Positive ControlsJSX · Traditional | Pharmacia, Inc. | 12/27/1983SE |
| K833180 | Gonochek-IiJSX · Traditional | E-Y Laboratories, Inc. | 11/14/1983SE |
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| K921421 | Legionella Reagens for Direct Fluorescent AntibodyLHL · Traditional | 07/28/1992SE |
| K903714 | E. Coli 0157 Latex TestGNA · Traditional | 01/24/1991SE |
| K894221 | Rosco PyrrJTO · Traditional | 09/28/1989SE |
| K883996 | X-Act Ldc/IndJSE · Traditional | 10/12/1988SE |
| K883995 | X-Act Urea/TdaJSE · Traditional | 10/12/1988SE |
| K871121 | Protect T.M.JTR · Traditional | 04/14/1987SE |
| K861142 | Master Kit BLRP · Traditional | 07/10/1986SESD |
| K861889 | D'Ala Rapid TestJTO · Traditional | 06/03/1986SE |
Questions and answers
When was Neisseria/Branhamella Differential Test cleared by the FDA?
Neisseria/Branhamella Differential Test (K870117) received a 510(k) decision of Substantially Equivalent on March 20, 1987, 67 days after the submission was received.
What is the product code of K870117?
The FDA product code is JSX – Kit, Identification, Neisseria Gonorrhoeae, a Class I (low risk) device regulated under 21 CFR 866.2660.