Bio-Bag Environmental Chamber (a & B)
FDA 510(k) K791724 · Marion Laboratories, Inc.
510(k) numberK791724
Submission
- Device name
- Bio-Bag Environmental Chamber (a & B)
- Applicant
- Marion Laboratories, Inc.
Mchenry, IL, US - Received
- August 30, 1979
- Decision date
- October 17, 1979
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- JTX – Transport Systems, Anaerobic
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 866.2900
- Specialty
- Microbiology
Other 510(k)s with product code JTX
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K901645 | Anaerobic Accu-Culshure(Tm)JTX · Traditional | Medical Laboratory Automation Systems, Inc. | 07/16/1990SE |
| K897151 | Acuson V328 and C5432 TransducersJTX · Traditional | Acuson Corp. | 07/03/1990SE |
| K882637 | Accu-Culshure TMJTX · Traditional | Accu-Med Corp. | 07/06/1988SE |
| K781376 | Standardize TGCL & TGCHJTX · Traditional | American Monitor Corp. | 09/14/1978SE |
| K780159 | AnaswabJTX · Traditional | Scott Laboratories, Inc. | 02/13/1978SE |
| K761241 | Pre-Duced Surgi-Swab & Transporter TubeJTX · Traditional | Gibco Laboratories Life Technologies, Inc. | 12/30/1976SE |
| K760063 | Specimen Collector, AnaerobicJTX · Traditional | Bd Becton Dickinson Vacutainer Systems Preanalytic | 08/03/1976SE |
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| 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 |
| K862123 | Biosphere Anaerobic Environmental DeviceKZJ · Traditional | 06/16/1986SE |
Questions and answers
When was Bio-Bag Environmental Chamber (a & B) cleared by the FDA?
Bio-Bag Environmental Chamber (a & B) (K791724) received a 510(k) decision of Substantially Equivalent on October 17, 1979, 48 days after the submission was received.
What is the product code of K791724?
The FDA product code is JTX – Transport Systems, Anaerobic, a Class I (low risk) device regulated under 21 CFR 866.2900.