AFFIRM VPIII MICROBIAL IDENTIFICATION TEST— 510(k) K931374

Name: FDA 510(k) clearance K931374
Creator: U.S. Food and Drug Administration
Published: 1993-06-15

Substantially Equivalent

Microprobe Corp.

FDA 510(k) clearance K931374 for AFFIRM VPIII MICROBIAL IDENTIFICATION TEST, Substantially Equivalent on 1993-06-15. Applicant: Microprobe Corp.. Device class: 1.

Clearance details

Applicant: Microprobe Corp.
Product code: Code MLA
Device class: Class 1
Regulation: 21 CFR 866.2660
Advisory panel: Microbiology
Date received: 1993-03-18
Decision date: 1993-06-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bothell, WA, US

Download summary PDF View on FDA.gov ↗

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Recalls naming K931374

K-number listed on FDA's recall record

Z-1394-2017 — BD AffirM VPIII Microbial Identification TestClass II·Terminated·Becton Dickinson & Co.·20150827

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K931374.

Data sourced from openFDA. This site is unofficial and independent of the FDA.