Remel Staph Latex Kit
FDA 510(k) K964315 · Remel, L.P.
510(k) numberK964315
Submission
- Device name
- Remel Staph Latex Kit
- Applicant
- Remel, L.P.
Augusta, GA, US - Received
- October 29, 1996
- Decision date
- February 7, 1997
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- JWX – Kit, Screening, Staphylococcus Aureus
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 866.2660
- Specialty
- Microbiology
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| K945538 | Staphaurex Plus(Tm)JWX · Traditional | Murex Diagnostics Limitd | 06/01/1995SE |
| K926173 | Staph-A-Lex(Tm) SystemJWX · Traditional | Trinity Laboratories, Inc. | 08/10/1993SE |
| K923212 | Slidex Staph-KitJWX · Traditional | Biomerieux Vitek, Inc. | 09/28/1992SE |
| K905617 | Visi-StaphJWX · Traditional | Connecticut Diagnostics, Ltd. | 03/29/1991SE |
| K902259 | Axiom Total Knee System, Tibial ComponentJWX · Traditional | Orthomet, Inc. | 06/18/1990SN |
| K874019 | StaphslideJWX · Traditional | Ncs Diagnostics, Inc. | 10/28/1987SE |
| K854278 | Neg Combo Breakpoint Panel Pos ComboJWX · Traditional | American Micro Scan | 03/04/1986SE |
| K855220 | V-Trend Kit Staph Latex TestJWX · Traditional | Texas Immunology, Inc. | 03/03/1986SE |
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| K961818 | Gentamicin Disk (120MCG)JTN · Traditional | 07/10/1996SE |
| K960313 | Mueller Hinton Agar with 2% NaciJTZ · Traditional | 03/25/1996SE |
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Questions and answers
When was Remel Staph Latex Kit cleared by the FDA?
Remel Staph Latex Kit (K964315) received a 510(k) decision of Substantially Equivalent on February 7, 1997, 101 days after the submission was received.
What is the product code of K964315?
The FDA product code is JWX – Kit, Screening, Staphylococcus Aureus, a Class I (low risk) device regulated under 21 CFR 866.2660.