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FDA 510(k)

PHYTONE

K-Number: K811653 · 1981-07-02

ApplicantAcumedia Manufacturers, Inc.
Decision Date1981-07-02
Product CodeJSK
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

PHYTONE is the device name listed in this FDA 510(k) record. The listed applicant is Acumedia Manufacturers, Inc.. It received FDA 510(k) clearance on 1981-07-02 under 510(k) number K811653. 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 PHYTONE?

PHYTONE is a medical device that received FDA 510(k) clearance on 1981-07-02. The listed applicant is Acumedia Manufacturers, Inc.. The 510(k) number is K811653.

When did PHYTONE receive FDA 510(k) clearance?

PHYTONE received FDA 510(k) clearance on 1981-07-02, under 510(k) number K811653.

Who is the listed applicant for PHYTONE?

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

What is the FDA product code for PHYTONE?

The FDA product code for PHYTONE is JSK.

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Other records listing Acumedia Manufacturers, 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.

K881534ANTIBIOTIC MEDIUM #9 POLYMYXIN BASE AGARK881540FLO AGARK881544LITTMAN AGARK881561TERGITOL 7 BROTHK881575SELECTIVE STREPTOCOCCUS AGARK881569STUARTS TRANSPORT MEDIUM

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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.K861824GENTAMICIN SULFATE SOLUTION (10MG 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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