Cleared Traditional

DEFINED FETAL BOVINE SERUM #A-1111

K870463 · Hyclone Laboratories, Inc. · Pathology
Mar 1987
Decision
49d
Days
Class 1
Risk

About This 510(k) Submission

K870463 is an FDA 510(k) clearance for the DEFINED FETAL BOVINE SERUM #A-1111, a Sera, Animal And Human (Class I — General Controls, product code KIS), submitted by Hyclone Laboratories, Inc. (Logan, US). The FDA issued a Cleared decision on March 24, 1987, 49 days after receiving the submission on February 3, 1987. This device falls under the Pathology review panel. Regulated under 21 CFR 864.2800.

Submission Details

510(k) Number K870463 FDA.gov
FDA Decision Cleared SESE
Date Received February 03, 1987
Decision Date March 24, 1987
Days to Decision 49 days
Submission Type Traditional
Review Panel Pathology (PA)
Summary —

Device Classification

Product Code KIS — Sera, Animal And Human
Device Class Class I — General Controls
CFR Regulation 21 CFR 864.2800

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