Cleared Traditional

NEPHELOMETRIC SOLID TURBIDITY STANDARD

K812220 · Hyland Therapeutic Div., Travenol Laboratories · Immunology
Aug 1981
Decision
12d
Days
Class 2
Risk

About This 510(k) Submission

K812220 is an FDA 510(k) clearance for the NEPHELOMETRIC SOLID TURBIDITY STANDARD, a Calibrator, Surrogate (Class II — Special Controls, product code JIW), submitted by Hyland Therapeutic Div., Travenol Laboratories (Mchenry, US). The FDA issued a Cleared decision on August 18, 1981, 12 days after receiving the submission on August 6, 1981. This device falls under the Immunology review panel. Regulated under 21 CFR 862.1150.

Submission Details

510(k) Number K812220 FDA.gov
FDA Decision Cleared SESE
Date Received August 06, 1981
Decision Date August 18, 1981
Days to Decision 12 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary —

Device Classification

Product Code JIW — Calibrator, Surrogate
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1150

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