Cleared Traditional

B2-MICROGLOBULIN CONTROL SET SERUM

K982471 · Boehringer Mannheim Corp. · Chemistry
Aug 1998
Decision
21d
Days
Class 1
Risk

About This 510(k) Submission

K982471 is an FDA 510(k) clearance for the B2-MICROGLOBULIN CONTROL SET SERUM, a Single (specified) Analyte Controls (assayed And Unassayed) (Class I — General Controls, product code JJX), submitted by Boehringer Mannheim Corp. (Pleasanton, US). The FDA issued a Cleared decision on August 6, 1998, 21 days after receiving the submission on July 16, 1998. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1660.

Submission Details

510(k) Number K982471 FDA.gov
FDA Decision Cleared SESE
Date Received July 16, 1998
Decision Date August 06, 1998
Days to Decision 21 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code JJX — Single (specified) Analyte Controls (assayed And Unassayed)
Device Class Class I — General Controls
CFR Regulation 21 CFR 862.1660

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