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FDA 510(k)

EXTUBE

K-Number: K781728 · 1978-12-20

ApplicantAnalytichem International, Inc.
Decision Date1978-12-20
Product CodeKEA
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

EXTUBE is the device name listed in this FDA 510(k) record. The listed applicant is Analytichem International, Inc.. It received FDA 510(k) clearance on 1978-12-20 under 510(k) number K781728. The device is classified under product code KEA. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EXTUBE?

EXTUBE is a medical device that received FDA 510(k) clearance on 1978-12-20. The listed applicant is Analytichem International, Inc.. The 510(k) number is K781728.

When did EXTUBE receive FDA 510(k) clearance?

EXTUBE received FDA 510(k) clearance on 1978-12-20, under 510(k) number K781728.

Who is the listed applicant for EXTUBE?

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

What is the FDA product code for EXTUBE?

The FDA product code for EXTUBE is KEA.

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 Analytichem International, 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.

K800061BOND ELUT COLUMNS

Related Devices (Code: KEA)

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.

K890997ZAVOS DISPOSABLE FILTRATION COLUMN (ZDFC)Atlantic Wholesale, Inc.K844948SYVA SOLID PHASE COLUMNSSyva Co.K842028CM-TRISACRYL M DEAE-TRISACRYL MLkb Instruments, Inc.K833320AMBERLITE CG50 RESIN, 100-200 MESHBiosan Laboratories, Inc.K833319BIO-REX 70 RESIN 100-200 MESH PH6.2Biosan Laboratories, Inc.K831027EXTRELUT QE EXTRACTION COLUMNSEmd Chemicals, Inc.

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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