CRYSTAL ENTERIC/NONFERMENTER ID SYSTEM— 510(k) K926018
Substantially EquivalentBecton Dickinson Microbiology Systems
FDA 510(k) clearance K926018 for CRYSTAL ENTERIC/NONFERMENTER ID SYSTEM, Substantially Equivalent on 1993-03-11. Applicant: Becton Dickinson Microbiology Systems. Device class: 1.
Clearance details
- Applicant
- Becton Dickinson Microbiology Systems
- Product code
- Code JSS
- Device class
- Class 1
- Regulation
- 21 CFR 866.2660
- Advisory panel
- Microbiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Cockeysville, MD, US
Recent devices under product code JSS
view allMore clearances from Becton Dickinson Microbiology Systems
view all- K993577 — CEFOTAXIME/CLAVULANIC, 30/10UG, BBL SENSI-DISC AND CEFTAZIDIME/CLAVULANIC ACID, 30/10UG, BBL SENSI-DISC
- K984631 — BDPROBETEC ET CHLAMYDIA TRACHOMATIS AND NEISSERIA GONORRHOEAE AMPLIFIED DNA ASSAY
- K981517 — CEFDINIR, 5 UG, SENSI-DISC
- K980683 — TROVAFLOXACIN 10G, SENSI-DISC
- K974578 — GREPAFLOXACIN, 5 MG, SENSI-DISC
Recalls naming K926018
K-number listed on FDA's recall record- Z-2041-2014 — BBL CrystaLEAD Enteric/Nonfermentor (E/NF) Identification (ID) System, catalog number 245000. in vitro diagnostic for the identification of aerobic gram-negative bacteria that belong to the family Enterobacteriaceae as well as some of the more frequently isolated glucose fermenting and nonfermenting gram-negative bacilli.
- Z-0699-2013 — Becton, Dickinson and Company, BBL Crystal Enteric/Nonfermenter ID Kit, Catalog # 24500, cartons of 20 kits, In-vitro diagnostic reagents for microbiological testing. The BBL Crystal Enteric/Nonfermentor (E/NF) identification (ID) System is for the identification of aerobic gram-negative bacteria that belong to the family Enterobacteriaceae as well as some of the more frequently isolated glucose fermenting and nonfermenting gram-negative bacilli.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K926018.
Data sourced from openFDA. This site is unofficial and independent of the FDA.