Brewer Gel for Campylobacter
FDA 510(k) K881502 · Fairleigh Dickinson Laboratories, Inc.
510(k) numberK881502
Submission
- Device name
- Brewer Gel for Campylobacter
- Applicant
- Fairleigh Dickinson Laboratories, Inc.
Abilene, TX, US - Received
- April 11, 1988
- Decision date
- April 27, 1988
- 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 |
|---|---|---|---|
| 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 |
| 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 |
More from Bd Becton Dickinson Vacutainer Systems Preanalytic
| 510(k) | Device | Decision |
|---|---|---|
| K896032 | Modified Elisa for ChlamydiaLJC · Traditional | 01/29/1990SE |
| K895187 | FDL, Inc.'s Transport SystemJTW · Traditional | 10/24/1989SE |
| K883266 | FDL Elisa for ChlamydiaLJC · Traditional | 10/25/1988SE |
| K875362 | Brewer Gel for AnaerobesKZJ · Traditional | 01/27/1988SE |
| K853307 | Direct Elisa for Herpes Simplex VirusGQN · Traditional | 12/23/1985SE |
| K850251 | Rotalok Surgical Hand Table · Traditional | 02/28/1985SE |
Questions and answers
When was Brewer Gel for Campylobacter cleared by the FDA?
Brewer Gel for Campylobacter (K881502) received a 510(k) decision of Substantially Equivalent on April 27, 1988, 16 days after the submission was received.
What is the product code of K881502?
The FDA product code is KZJ – Device, Gas Generating, a Class I (low risk) device regulated under 21 CFR 866.2580.