Gas Generating Kit System for Campylob.
FDA 510(k) K802494 · Oxoid U.S.A., Inc.
510(k) numberK802494
Submission
- Device name
- Gas Generating Kit System for Campylob.
- Applicant
- Oxoid U.S.A., Inc.
Mchenry, IL, US - Received
- October 10, 1980
- Decision date
- November 12, 1980
- 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 |
| K844571 | Campypak Plus W/Palladium Catalyst Dispos. HydrogeKZJ · Traditional | Bd Becton Dickinson Vacutainer Systems Preanalytic | 01/30/1985SE |
| K841117 | Gaspak Plus Dispos. Hydrogen &KZJ · Traditional | Bd Becton Dickinson Vacutainer Systems Preanalytic | 04/04/1984SE |
More from Bd Becton Dickinson Vacutainer Systems Preanalytic
| 510(k) | Device | Decision |
|---|---|---|
| K891593 | Listeria Selective Enrichment MediumJSI · Traditional | 06/09/1989SE |
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| K884208 | Listeria Selective Medium (Oxford Formulation)KZI · Traditional | 10/25/1988SE |
| K874303 | Staphylase TestLHT · Traditional | 11/06/1987SE |
| K872956 | Sorbitol Macconkey Agar No. 3 CM 813JSI · Traditional | 08/10/1987SE |
| K872135 | Mcbride Medium CM 819JSJ · Traditional | 06/15/1987SE |
| K870945 | Rabbit Plasma Fibrinogen Supplement SR 122JTL · Traditional | 06/10/1987SE |
| K862946 | Oxoid Signal Blood Culture SystemJSG · Traditional | 11/05/1986SE |
| K855236 | Diagnostic Reagent Tst-RplaGTN · Traditional | 11/04/1986SE |
| K855235 | Diagnostic Reagent Pet-RplaJSP · Traditional | 11/04/1986SE |
Questions and answers
When was Gas Generating Kit System for Campylob. cleared by the FDA?
Gas Generating Kit System for Campylob. (K802494) received a 510(k) decision of Substantially Equivalent on November 12, 1980, 33 days after the submission was received.
What is the product code of K802494?
The FDA product code is KZJ – Device, Gas Generating, a Class I (low risk) device regulated under 21 CFR 866.2580.