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FDA 510(k)

CENTRICELL(TM)

K-Number: K871290 · 1987-08-05

ApplicantPolysciences, Inc.
Decision Date1987-08-05
Product CodeJJH
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

CENTRICELL(TM) is the device name listed in this FDA 510(k) record. The listed applicant is Polysciences, Inc.. It received FDA 510(k) clearance on 1987-08-05 under 510(k) number K871290. The device is classified under product code JJH. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CENTRICELL(TM)?

CENTRICELL(TM) is a medical device that received FDA 510(k) clearance on 1987-08-05. The listed applicant is Polysciences, Inc.. The 510(k) number is K871290.

When did CENTRICELL(TM) receive FDA 510(k) clearance?

CENTRICELL(TM) received FDA 510(k) clearance on 1987-08-05, under 510(k) number K871290.

Who is the listed applicant for CENTRICELL(TM)?

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

What is the FDA product code for CENTRICELL(TM)?

The FDA product code for CENTRICELL(TM) is JJH.

Related Clinical Trials

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.

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Other records listing Polysciences, 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.

K923349FUNGI FLUOR KITK780146T3 STI KIT

Related Devices (Code: JJH)

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.

K113731ESENSOR RESPIRATORY VIRAL PANELClinical Micro Sensors, Inc.K960298VIVASPIN 4 10,000 MWVivascience, Inc.K943965VIVAPORE 10Vivascience, Inc.K943966VIVAPORE 2Vivascience, Inc.K941326ULTRAFREE-CLMillipore Corp.K935496NANOSEP N10Intersep , Ltd.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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