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FDA 510(k)

GENTAMICIN SULFATE SOLUTION (10MG GENTAMICIN)

K-Number: K861824 · 1986-05-20

ApplicantFlow Laboratories, Inc.
Decision Date1986-05-20
Product CodeJSK
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

GENTAMICIN SULFATE SOLUTION (10MG GENTAMICIN) 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 1986-05-20 under 510(k) number K861824. The device is classified under product code JSK. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GENTAMICIN SULFATE SOLUTION (10MG GENTAMICIN)?

GENTAMICIN SULFATE SOLUTION (10MG GENTAMICIN) is a medical device that received FDA 510(k) clearance on 1986-05-20. The listed applicant is Flow Laboratories, Inc.. The 510(k) number is K861824.

When did GENTAMICIN SULFATE SOLUTION (10MG GENTAMICIN) receive FDA 510(k) clearance?

GENTAMICIN SULFATE SOLUTION (10MG GENTAMICIN) received FDA 510(k) clearance on 1986-05-20, under 510(k) number K861824.

Who is the listed applicant for GENTAMICIN SULFATE SOLUTION (10MG GENTAMICIN)?

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 GENTAMICIN SULFATE SOLUTION (10MG GENTAMICIN)?

The FDA product code for GENTAMICIN SULFATE SOLUTION (10MG GENTAMICIN) is JSK.

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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-12K861791PENICILLIN-STREPTOMYCIN-FUNGIZONEK861823GENTAMICIN SULFATE SOLUTION (50MG GENTAMICIN)K860762GAMMA-FREE HORSE SERUMK860752GOAT SERUM (29-391-54)

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Related Devices (Code: JSK)

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.

K881949ATS NAC-PAC SETAlpha-Tec Systems, Inc.K881879ATS M/15 PHOSPHATE BUFFER, PRODUCT #034-42Alpha-Tec Systems, Inc.K881566HEMOGLOBIN POWDERAcumedia Manufacturers, Inc.K861997PENICILLIN-STREPTOMYCIN-FUNGIZONE MIXTUREHazleton Research Products, Inc.K861791PENICILLIN-STREPTOMYCIN-FUNGIZONEFlow Laboratories, Inc.K861823GENTAMICIN SULFATE SOLUTION (50MG GENTAMICIN)Flow 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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