Cleared Traditional

ELECSYS SERUM B-CROSSLAPS/SERUM IMMUNOASSAY

K993706 · Roche Diagnostics Corp. · Chemistry
Jul 2000
Decision
265d
Days
Class 1
Risk

About This 510(k) Submission

K993706 is an FDA 510(k) clearance for the ELECSYS SERUM B-CROSSLAPS/SERUM IMMUNOASSAY, a Column Chromatography & Color Development, Hydroxyproline (Class I — General Controls, product code JMM), submitted by Roche Diagnostics Corp. (Indianapolis, US). The FDA issued a Cleared decision on July 24, 2000, 265 days after receiving the submission on November 2, 1999. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1400.

Submission Details

510(k) Number K993706 FDA.gov
FDA Decision Cleared SESE
Date Received November 02, 1999
Decision Date July 24, 2000
Days to Decision 265 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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