VITEK GRAM POSITIVE IDENTIFICATION CARD (GPI)— 510(k) K952095
Substantially EquivalentBiomerieux Vitek, Inc.
FDA 510(k) clearance K952095 for VITEK GRAM POSITIVE IDENTIFICATION CARD (GPI), Substantially Equivalent on 1996-03-12. Applicant: Biomerieux Vitek, Inc.. Device class: 1.
Clearance details
- Applicant
- Biomerieux Vitek, Inc.
- Product code
- Code LQL
- Device class
- Class 1
- Regulation
- 21 CFR 866.2660
- Advisory panel
- Microbiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Hazelwood, MO, US
Recent devices under product code LQL
view allMore clearances from Biomerieux Vitek, Inc.
view allRecalls naming K952095
K-number listed on FDA's recall record- Z-0074-2018 — VITEK2 GP-ID, REF 21342 IVD
- Z-3134-2017 — VITEK(R) 2 GP, REF 21342, IVD, UDI 03573026131920, bioMerieux, Inc. VITEK(R) 2 is an automated system consisting of instruments, software and reagent cards designed for the identification and antimicrobial susceptibility testing of bacteria and yeast. The VITEK¿ 2 utilizes growth based biochemical patterns to determine identification. The VITEK¿ 2 provides minimal inhibitory concentration (MIC) results for most organism/drug combinations as well as a category interpretation (S, I, or R) consistent with accepted criteria
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K952095.
Data sourced from openFDA. This site is unofficial and independent of the FDA.