FDA 510(k)

HUMAN AB SERUM - STERILE FILTERED

K-Number: K861813 · 1986-05-20

ApplicantHazleton Research Products, Inc.

Decision Date1986-05-20

Product CodeKIS

Advisory CommitteeHE

DecisionSubstantially Equivalent

Device Summary

HUMAN AB SERUM - STERILE FILTERED is the device name listed in this FDA 510(k) record. The listed applicant is Hazleton Research Products, Inc.. It received FDA 510(k) clearance on 1986-05-20 under 510(k) number K861813. The device is classified under product code KIS. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HUMAN AB SERUM - STERILE FILTERED?

HUMAN AB SERUM - STERILE FILTERED is a medical device that received FDA 510(k) clearance on 1986-05-20. The listed applicant is Hazleton Research Products, Inc.. The 510(k) number is K861813.

When did HUMAN AB SERUM - STERILE FILTERED receive FDA 510(k) clearance?

HUMAN AB SERUM - STERILE FILTERED received FDA 510(k) clearance on 1986-05-20, under 510(k) number K861813.

Who is the listed applicant for HUMAN AB SERUM - STERILE FILTERED?

The FDA 510(k) record lists Hazleton Research Products, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HUMAN AB SERUM - STERILE FILTERED?

The FDA product code for HUMAN AB SERUM - STERILE FILTERED is KIS.

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Other records listing Hazleton Research Products, Inc. as applicant

K861997PENICILLIN-STREPTOMYCIN-FUNGIZONE MIXTURE K861996DULBECCO'S MEM WITH 4.5 G/L GLUCOSE MEDIUM K861886DMEM & HAM'S F-12 (1:1) POWDERED MEDIUM K861869GENTAMICIN-50MG/ML K861872ISCOVE'S (MODIFIED) DULBECCO'S MEDIUM K861871NCTC 109 MEDIUM

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Related Devices (Code: KIS)

K881287ANIMAL AND HUMAN SERACell Culture Laboratories K880471BOVINE CALF SERUM SUPPLEMENTED #A-2159Hyclone Laboratories, Inc.K880470BOVINE CALF SERUM CATALOG #A-2119Hyclone Laboratories, Inc.K872847SOLCOSERYL TISSUE CULTURE GROWTH SUPPLEMENTCandace Lane Corp.K870580MLC NORMAL SERUMRjo Biologicals, Inc.K870938FETAL BOVINE SERUMHyclone Laboratories, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.