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FDA 510(k)

AMERLEX-MAB FT4 KIT

K-Number: K894091 · 1989-08-03

ApplicantAmersham Corp.
Decision Date1989-08-03
Product CodeCEC
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

AMERLEX-MAB FT4 KIT is the device name listed in this FDA 510(k) record. The listed applicant is Amersham Corp.. It received FDA 510(k) clearance on 1989-08-03 under 510(k) number K894091. The device is classified under product code CEC. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AMERLEX-MAB FT4 KIT?

AMERLEX-MAB FT4 KIT is a medical device that received FDA 510(k) clearance on 1989-08-03. The listed applicant is Amersham Corp.. The 510(k) number is K894091.

When did AMERLEX-MAB FT4 KIT receive FDA 510(k) clearance?

AMERLEX-MAB FT4 KIT received FDA 510(k) clearance on 1989-08-03, under 510(k) number K894091.

Who is the listed applicant for AMERLEX-MAB FT4 KIT?

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

What is the FDA product code for AMERLEX-MAB FT4 KIT?

The FDA product code for AMERLEX-MAB FT4 KIT is CEC.

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Other records listing Amersham Corp. as applicant

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K914135AMERLITE(TM) PROLACTIN-30 ASSAY, LAN.0086/2086K912733AMERLEX-M SPECIFIC ESTROL(UNCONJUGATED) RIA KITK912766AMERLITE CK-MB ASSAYK904666AMERLITE TSH-60 ASSAY PRODUCT CODE: LAN. 0008/2008K902760AMERSHAM TSH CONTROL SERAK901832GADOLINIUM-153 BONE DENSITOMETER SOURCES GDC.10415

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Related Devices (Code: CEC)

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.

K240273Access Free T4Beckman Coulter, Inc.K220456Elecsys FT4 IVRoche DiagnosticsK182423MAGLUMI 2000 FT4Shenzhen New Industries Biomedical Engineering Co., Ltd.K181233Elecsys FT4 IIIRoche DiagnosticsK173122Abbott Architect Free T4Abbott LaboratoriesK152422FREND™ Free T4 Test SystemNanoentek USA, 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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