Biosphere Anaerobic Environmental Device
FDA 510(k) K862123 · Marion Laboratories, Inc.
510(k) numberK862123
Submission
- Device name
- Biosphere Anaerobic Environmental Device
- Applicant
- Marion Laboratories, Inc.
Kansas City, MI, US - Received
- June 3, 1986
- Decision date
- June 16, 1986
- 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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| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K881502 | Brewer Gel for CampylobacterKZJ · Traditional | Fairleigh Dickinson Laboratories, Inc. | 04/27/1988SE |
| K875362 | Brewer Gel for AnaerobesKZJ · Traditional | Fairleigh Dickinson Laboratories, Inc. | 01/27/1988SE |
| K872782 | Bbl(R) Gaspak CO2 Pouch(Tm)KZJ · Traditional | Bd Becton Dickinson Vacutainer Systems Preanalytic | 08/06/1987SE |
| K871709 | Anaerobic Transport Pouch (Catalyst-Free)KZJ · Traditional | Difco Laboratories, Inc. | 05/15/1987SE |
| K871238 | AnabagKZJ · Traditional | Scott Laboratories, Inc. | 04/03/1987SE |
| 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 |
| K832229 | BBL Anagel PowderKZJ · Traditional | Bd Becton Dickinson Vacutainer Systems Preanalytic | 08/12/1983SE |
More from Bd Becton Dickinson Vacutainer Systems Preanalytic
| 510(k) | Device | Decision |
|---|---|---|
| K883391 | Polymer Adhesive BandageNAD · Traditional | 03/23/1989SN |
| K875182 | Modified Labeling for Toxi-Lab THC ScreenDKE · Traditional | 07/05/1988SE |
| K875181 | Modified Labeling for Toxi-Lab Broad Spectrum · Traditional | 05/27/1988SE |
| K874554 | Enviclusive (TM)NAD · Traditional | 03/11/1988SE |
| K874552 | Envisan PadKOZ · Traditional | 01/22/1988SN |
| K874551 | Envinet(Tm)EFQ · Traditional | 01/22/1988SN |
| K874553 | Envisan PasteKOZ · Traditional | 12/18/1987SN |
| K870864 | Culturette Brand CDT Clostridium Difficile TestLLH · Traditional | 04/14/1987SE |
| K863485 | Modification of Cdt(Tm) Clostridium TestLLH · Traditional | 09/17/1986SE |
| K853073 | Culturette Brand 10-MINUTE Group a Strep I.D.GTZ · Traditional | 08/01/1985SE |
Questions and answers
When was Biosphere Anaerobic Environmental Device cleared by the FDA?
Biosphere Anaerobic Environmental Device (K862123) received a 510(k) decision of Substantially Equivalent on June 16, 1986, 13 days after the submission was received.
What is the product code of K862123?
The FDA product code is KZJ – Device, Gas Generating, a Class I (low risk) device regulated under 21 CFR 866.2580.