Cleared Traditional

BOVINE CALF SERUM SUPPLEMENTED #A-2159

K880471 · Hyclone Laboratories, Inc. · Pathology
Apr 1988
Decision
61d
Days
Class 1
Risk

About This 510(k) Submission

K880471 is an FDA 510(k) clearance for the BOVINE CALF SERUM SUPPLEMENTED #A-2159, 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 April 4, 1988, 61 days after receiving the submission on February 3, 1988. This device falls under the Pathology review panel. Regulated under 21 CFR 864.2800.

Submission Details

510(k) Number K880471 FDA.gov
FDA Decision Cleared SESE
Date Received February 03, 1988
Decision Date April 04, 1988
Days to Decision 61 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

Similar Devices — KIS Sera, Animal And Human

All 44
ANIMAL AND HUMAN SERA
K881287 · Cell Culture Laboratories · Apr 1988
BOVINE CALF SERUM CATALOG #A-2119
K880470 · Hyclone Laboratories, Inc. · Apr 1988
SOLCOSERYL TISSUE CULTURE GROWTH SUPPLEMENT
K872847 · Candace Lane Corp. · Aug 1987
MLC NORMAL SERUM
K870580 · Rjo Biologicals, Inc. · Apr 1987
FETAL BOVINE SERUM
K870938 · Hyclone Laboratories, Inc. · Mar 1987
DEFINED FETAL BOVINE SERUM #A-1111
K870463 · Hyclone Laboratories, Inc. · Mar 1987