Campypak Plus W/Palladium Catalyst Dispos. Hydroge
FDA 510(k) K844571 · Bd Becton Dickinson Vacutainer Systems Preanalytic
510(k) numberK844571
Submission
- Device name
- Campypak Plus W/Palladium Catalyst Dispos. Hydroge
- Applicant
- Bd Becton Dickinson Vacutainer Systems Preanalytic
Washington, DC, US - Received
- November 23, 1984
- Decision date
- January 30, 1985
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- KZJ – Device, Gas Generating
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 866.2580
- Specialty
- Microbiology
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| K881502 | Brewer Gel for CampylobacterKZJ · Traditional | Fairleigh Dickinson Laboratories, Inc. | 04/27/1988SE |
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| K871709 | Anaerobic Transport Pouch (Catalyst-Free)KZJ · Traditional | Difco Laboratories, Inc. | 05/15/1987SE |
| K871238 | AnabagKZJ · Traditional | Scott Laboratories, Inc. | 04/03/1987SE |
| K862123 | Biosphere Anaerobic Environmental DeviceKZJ · Traditional | Marion Laboratories, Inc. | 06/16/1986SE |
| K853534 | BBL Campy PouchKZJ · Traditional | Bd Becton Dickinson Vacutainer Systems Preanalytic | 08/29/1985SE |
| K845008 | Bio-Bag Environmental Chamber -Type A-Multi-PlateKZJ · Traditional | Marion Laboratories, Inc. | 03/05/1985SE |
| K841117 | Gaspak Plus Dispos. Hydrogen &KZJ · Traditional | Bd Becton Dickinson Vacutainer Systems Preanalytic | 04/04/1984SE |
| K832229 | BBL Anagel PowderKZJ · Traditional | Bd Becton Dickinson Vacutainer Systems Preanalytic | 08/12/1983SE |
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Questions and answers
When was Campypak Plus W/Palladium Catalyst Dispos. Hydroge cleared by the FDA?
Campypak Plus W/Palladium Catalyst Dispos. Hydroge (K844571) received a 510(k) decision of Substantially Equivalent on January 30, 1985, 68 days after the submission was received.
What is the product code of K844571?
The FDA product code is KZJ – Device, Gas Generating, a Class I (low risk) device regulated under 21 CFR 866.2580.