DeviceClearance

NEOBASE NON-DERIVATIZED MSMS KIT, MODEL 3040— 510(k) K083130

Substantially Equivalent

Perkinelmer, Inc.

FDA 510(k) clearance K083130 for NEOBASE NON-DERIVATIZED MSMS KIT, MODEL 3040, Substantially Equivalent on 2009-07-09. Applicant: Perkinelmer, Inc.. Device class: 2.

Clearance details

Applicant
Perkinelmer, Inc.
Product code
Code NQL
Device class
Class 2
Regulation
21 CFR 862.1055
Advisory panel
Clinical Chemistry
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Indianapolis, IN, US
Download summary PDFView on FDA.gov ↗

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Recalls naming K083130

K-number listed on FDA's recall record

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K083130.

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