Cleared Traditional

PYRILINKS POLYCLONAL ASSAY KIT

K952026 · Metra Biosystems, Inc. · Chemistry
Nov 1995
Decision
186d
Days
Class 1
Risk

About This 510(k) Submission

K952026 is an FDA 510(k) clearance for the PYRILINKS POLYCLONAL ASSAY KIT, a Column Chromatography & Color Development, Hydroxyproline (Class I — General Controls, product code JMM), submitted by Metra Biosystems, Inc. (Laurel, US). The FDA issued a Cleared decision on November 3, 1995, 186 days after receiving the submission on May 1, 1995. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1400.

Submission Details

510(k) Number K952026 FDA.gov
FDA Decision Cleared SESE
Date Received May 01, 1995
Decision Date November 03, 1995
Days to Decision 186 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code JMM — Column Chromatography & Color Development, Hydroxyproline
Device Class Class I — General Controls
CFR Regulation 21 CFR 862.1400

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