Cleared Traditional

REFRACTOMETRIC, TOTAL PROTEIN

K933218 · Pyramid Biological Corp. · Chemistry
Feb 1994
Decision
231d
Days
Class 1
Risk

About This 510(k) Submission

K933218 is an FDA 510(k) clearance for the REFRACTOMETRIC, TOTAL PROTEIN, 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 February 17, 1994, 231 days after receiving the submission on July 1, 1993. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1660.

Submission Details

510(k) Number K933218 FDA.gov
FDA Decision Cleared SESE
Date Received July 01, 1993
Decision Date February 17, 1994
Days to Decision 231 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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