Cleared Traditional

FETAL BOVINE SERUM

K870938 · Hyclone Laboratories, Inc. · Pathology
Mar 1987
Decision
22d
Days
Class 1
Risk

About This 510(k) Submission

K870938 is an FDA 510(k) clearance for the FETAL BOVINE SERUM, 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 31, 1987, 22 days after receiving the submission on March 9, 1987. This device falls under the Pathology review panel. Regulated under 21 CFR 864.2800.

Submission Details

510(k) Number K870938 FDA.gov
FDA Decision Cleared SESE
Date Received March 09, 1987
Decision Date March 31, 1987
Days to Decision 22 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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