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FDA 510(k)

AMERLIITE FT4 ASSAY LAN.0006/2006 240/144 TEST KIT

K-Number: K883123 · 1988-12-22

ApplicantAmersham Corp.
Decision Date1988-12-22
Product CodeCEC
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

AMERLIITE FT4 ASSAY LAN.0006/2006 240/144 TEST 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 1988-12-22 under 510(k) number K883123. 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 AMERLIITE FT4 ASSAY LAN.0006/2006 240/144 TEST KIT?

AMERLIITE FT4 ASSAY LAN.0006/2006 240/144 TEST KIT is a medical device that received FDA 510(k) clearance on 1988-12-22. The listed applicant is Amersham Corp.. The 510(k) number is K883123.

When did AMERLIITE FT4 ASSAY LAN.0006/2006 240/144 TEST KIT receive FDA 510(k) clearance?

AMERLIITE FT4 ASSAY LAN.0006/2006 240/144 TEST KIT received FDA 510(k) clearance on 1988-12-22, under 510(k) number K883123.

Who is the listed applicant for AMERLIITE FT4 ASSAY LAN.0006/2006 240/144 TEST 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 AMERLIITE FT4 ASSAY LAN.0006/2006 240/144 TEST KIT?

The FDA product code for AMERLIITE FT4 ASSAY LAN.0006/2006 240/144 TEST KIT is CEC.

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Other records listing Amersham Corp. 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.

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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