Cleared Traditional

SERUM PROTEIN CONTROLS

K944515 · Pyramid Biological Corp. · Chemistry
Nov 1994
Decision
63d
Days
Class 1
Risk

About This 510(k) Submission

K944515 is an FDA 510(k) clearance for the SERUM PROTEIN CONTROLS, a Single (specified) Analyte Controls (assayed And Unassayed) (Class I — General Controls, product code JJX), submitted by Pyramid Biological Corp. (Van Nuys, US). The FDA issued a Cleared decision on November 17, 1994, 63 days after receiving the submission on September 15, 1994. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1660.

Submission Details

510(k) Number K944515 FDA.gov
FDA Decision Cleared SESE
Date Received September 15, 1994
Decision Date November 17, 1994
Days to Decision 63 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement

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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