Cleared Traditional

ALPHACALF SERUM

K884654 · Hyclone Laboratories, Inc. · Pathology
Nov 1988
Decision
23d
Days
Class 1
Risk

About This 510(k) Submission

K884654 is an FDA 510(k) clearance for the ALPHACALF SERUM, a Media And Components, Synthetic Cell And Tissue Culture (Class I — General Controls, product code KIT), submitted by Hyclone Laboratories, Inc. (Logan, US). The FDA issued a Cleared decision on November 30, 1988, 23 days after receiving the submission on November 7, 1988. This device falls under the Pathology review panel. Regulated under 21 CFR 864.2220.

Submission Details

510(k) Number K884654 FDA.gov
FDA Decision Cleared SESE
Date Received November 07, 1988
Decision Date November 30, 1988
Days to Decision 23 days
Submission Type Traditional
Review Panel Pathology (PA)
Summary —

Device Classification

Product Code KIT — Media And Components, Synthetic Cell And Tissue Culture
Device Class Class I — General Controls
CFR Regulation 21 CFR 864.2220

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