Dryslide Cartarrhalis
FDA 510(k) K954783 · Difco Laboratories, Inc.
510(k) numberK954783
Submission
- Device name
- Dryslide Cartarrhalis
- Applicant
- Difco Laboratories, Inc.
Livouia, MI, US - Received
- October 17, 1995
- Decision date
- February 6, 1996
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- JTO – Discs, Strips And Reagents, Microorganism Differentiation
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 866.2660
- Specialty
- Microbiology
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| K962966 | Ids Rapid CB Plus SystemJTO · Traditional | Innovative Diagnostic Systems, Inc. | 10/08/1996SE |
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| K960996 | M. Cat Butyrate DiskJTO · Traditional | Hardy Diagnostics | 04/18/1996SE |
| K955826 | Gibson Id-M. Cat.JTO · Traditional | Gibson Laboratories, Inc. | 02/29/1996SE |
| K954812 | Lyfo(Tm) Differiental Disk-PyrJTO · Traditional | Microbiologics, Inc. | 12/20/1995SE |
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| K963508 | Dispens-O-Disc MeropenemJTN · Traditional | 09/26/1996SE |
| K961148 | Cefepime Dispans-O-Disc (Cefeplime - 30MCG)JTW · Traditional | 04/26/1996SE |
| K954784 | Dryside NeisseriaLTS · Traditional | 01/30/1996SE |
| 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 |
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Questions and answers
When was Dryslide Cartarrhalis cleared by the FDA?
Dryslide Cartarrhalis (K954783) received a 510(k) decision of Substantially Equivalent on February 6, 1996, 112 days after the submission was received.
What is the product code of K954783?
The FDA product code is JTO – Discs, Strips And Reagents, Microorganism Differentiation, a Class I (low risk) device regulated under 21 CFR 866.2660.