Dryside Neisseria
FDA 510(k) K954784 · Difco Laboratories, Inc.
510(k) numberK954784
Submission
- Device name
- Dryside Neisseria
- Applicant
- Difco Laboratories, Inc.
Livouia, MI, US - Received
- October 17, 1995
- Decision date
- January 30, 1996
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- LTS – Test Reagents, Neisseria Gonorrhoeae Biochemical
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 866.2660
- Specialty
- Microbiology
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|---|---|---|
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| K961148 | Cefepime Dispans-O-Disc (Cefeplime - 30MCG)JTW · Traditional | 04/26/1996SE |
| K954783 | Dryslide CartarrhalisJTO · Traditional | 02/06/1996SE |
| K953129 | Esp Culture System - MycoMDB · Traditional | 12/26/1995SE |
| K950706 | Dryslide CoagulaseJTL · Traditional | 05/16/1995SE |
| K944275 | Dispens-O-Disc Piperacillin 100 Mcg./Tazobactam 10 Mcg.JTN · Traditional | 12/19/1994SE |
| K941016 | Dispens-O-Disc(Tm) NitrocefinJTO · Traditional | 06/30/1994SE |
| K934894 | Cultureswab Transport SystemJTW · Traditional | 02/22/1994SE |
Questions and answers
When was Dryside Neisseria cleared by the FDA?
Dryside Neisseria (K954784) received a 510(k) decision of Substantially Equivalent on January 30, 1996, 105 days after the submission was received.
What is the product code of K954784?
The FDA product code is LTS – Test Reagents, Neisseria Gonorrhoeae Biochemical, a Class I (low risk) device regulated under 21 CFR 866.2660.