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FDA 510(k)

GAMMA-FREE HORSE SERUM

K-Number: K860762 · 1986-03-10

ApplicantFlow Laboratories, Inc.
Decision Date1986-03-10
Product CodeKIS
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

GAMMA-FREE HORSE SERUM is the device name listed in this FDA 510(k) record. The listed applicant is Flow Laboratories, Inc.. It received FDA 510(k) clearance on 1986-03-10 under 510(k) number K860762. 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 GAMMA-FREE HORSE SERUM?

GAMMA-FREE HORSE SERUM is a medical device that received FDA 510(k) clearance on 1986-03-10. The listed applicant is Flow Laboratories, Inc.. The 510(k) number is K860762.

When did GAMMA-FREE HORSE SERUM receive FDA 510(k) clearance?

GAMMA-FREE HORSE SERUM received FDA 510(k) clearance on 1986-03-10, under 510(k) number K860762.

Who is the listed applicant for GAMMA-FREE HORSE SERUM?

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

What is the FDA product code for GAMMA-FREE HORSE SERUM?

The FDA product code for GAMMA-FREE HORSE SERUM is KIS.

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Other records listing Flow Laboratories, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K861897UNISKAN IIK862066TITERTEK MICROPLATE WASHER S-12K861824GENTAMICIN SULFATE SOLUTION (10MG GENTAMICIN)K861823GENTAMICIN SULFATE SOLUTION (50MG GENTAMICIN)K861791PENICILLIN-STREPTOMYCIN-FUNGIZONEK860752GOAT SERUM (29-391-54)

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Related Devices (Code: KIS)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K881287ANIMAL AND HUMAN SERACell Culture LaboratoriesK880471BOVINE 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.

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