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FDA 510(k)

PENICILLIN-STREPTOMYCIN-FUNGIZONE

K-Number: K861791 · 1986-05-20

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

Device Summary

PENICILLIN-STREPTOMYCIN-FUNGIZONE 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 K861791. 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 PENICILLIN-STREPTOMYCIN-FUNGIZONE?

PENICILLIN-STREPTOMYCIN-FUNGIZONE 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 K861791.

When did PENICILLIN-STREPTOMYCIN-FUNGIZONE receive FDA 510(k) clearance?

PENICILLIN-STREPTOMYCIN-FUNGIZONE received FDA 510(k) clearance on 1986-05-20, under 510(k) number K861791.

Who is the listed applicant for PENICILLIN-STREPTOMYCIN-FUNGIZONE?

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 PENICILLIN-STREPTOMYCIN-FUNGIZONE?

The FDA product code for PENICILLIN-STREPTOMYCIN-FUNGIZONE 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-12K861824GENTAMICIN SULFATE SOLUTION (10MG GENTAMICIN)K861823GENTAMICIN 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.K861824GENTAMICIN SULFATE SOLUTION (10MG GENTAMICIN)Flow 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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