Bbl(R) Gaspak CO2 Pouch(Tm)
FDA 510(k) K872782 · Bd Becton Dickinson Vacutainer Systems Preanalytic
510(k) numberK872782
Submission
- Device name
- Bbl(R) Gaspak CO2 Pouch(Tm)
- Applicant
- Bd Becton Dickinson Vacutainer Systems Preanalytic
Franklin Lakes, NJ, US - Received
- July 14, 1987
- Decision date
- August 6, 1987
- 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
Other 510(k)s with product code KZJ
| 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 |
| 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 |
| K832229 | BBL Anagel PowderKZJ · Traditional | Bd Becton Dickinson Vacutainer Systems Preanalytic | 08/12/1983SE |
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Questions and answers
When was Bbl(R) Gaspak CO2 Pouch(Tm) cleared by the FDA?
Bbl(R) Gaspak CO2 Pouch(Tm) (K872782) received a 510(k) decision of Substantially Equivalent on August 6, 1987, 23 days after the submission was received.
What is the product code of K872782?
The FDA product code is KZJ – Device, Gas Generating, a Class I (low risk) device regulated under 21 CFR 866.2580.