GC II AGAR WITH ISOVITALEX— 510(k) K932882
Substantially EquivalentBecton Dickinson Microbiology Systems
FDA 510(k) clearance K932882 for GC II AGAR WITH ISOVITALEX, Substantially Equivalent on 1993-09-24. Applicant: Becton Dickinson Microbiology Systems. Device class: 2.
Clearance details
- Applicant
- Becton Dickinson Microbiology Systems
- Product code
- Code JSO
- Device class
- Class 2
- Regulation
- 21 CFR 866.1700
- Advisory panel
- Microbiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Cockeysville, MD, US
Recent devices under product code JSO
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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
Adverse events under product code JSO
product code JSO- Malfunction
- 602
- Total
- 602
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.