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FDA 510(k)

GENTAMICIN-50MG/ML

K-Number: K861869 · 1986-05-29

ApplicantHazleton Research Products, Inc.
Decision Date1986-05-29
Product CodeKIT
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

GENTAMICIN-50MG/ML 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 1986-05-29 under 510(k) number K861869. The device is classified under product code KIT. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GENTAMICIN-50MG/ML?

GENTAMICIN-50MG/ML is a medical device that received FDA 510(k) clearance on 1986-05-29. The listed applicant is Hazleton Research Products, Inc.. The 510(k) number is K861869.

When did GENTAMICIN-50MG/ML receive FDA 510(k) clearance?

GENTAMICIN-50MG/ML received FDA 510(k) clearance on 1986-05-29, under 510(k) number K861869.

Who is the listed applicant for GENTAMICIN-50MG/ML?

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 GENTAMICIN-50MG/ML?

The FDA product code for GENTAMICIN-50MG/ML is KIT.

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Other records listing Hazleton Research Products, 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.

K861997PENICILLIN-STREPTOMYCIN-FUNGIZONE MIXTUREK861996DULBECCO'S MEM WITH 4.5 G/L GLUCOSE MEDIUMK861886DMEM & HAM'S F-12 (1:1) POWDERED MEDIUMK861871NCTC 109 MEDIUMK861872ISCOVE'S (MODIFIED) DULBECCO'S MEDIUMK861867MEM ALPHA EAGLE MEDIUM

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Related Devices (Code: KIT)

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.

K892938AMNIO-GROW TMInovar Biologicals, Inc.K890700MELANOCYTE GROWTH MEDIUM (MGM)Clonetics Corp.K890701ENDOTHELIAL GROWTH MEDIUM (EGM)Clonetics Corp.K890482ABC, ABC-1X, ABC(TM)Cell Ent., Inc.K884654ALPHACALF SERUMHyclone Laboratories, Inc.K884572RPMI-1640 HYBRI-MAX, PROD. NO. R5382Sigma Chemical Co.

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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