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FDA 510(k)

AMERLEX T-4 RIA KIT

K-Number: K800300 · 1980-03-05

ApplicantAmersham Corp.
Decision Date1980-03-05
Product CodeCDX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

AMERLEX T-4 RIA 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 1980-03-05 under 510(k) number K800300. The device is classified under product code CDX. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AMERLEX T-4 RIA KIT?

AMERLEX T-4 RIA KIT is a medical device that received FDA 510(k) clearance on 1980-03-05. The listed applicant is Amersham Corp.. The 510(k) number is K800300.

When did AMERLEX T-4 RIA KIT receive FDA 510(k) clearance?

AMERLEX T-4 RIA KIT received FDA 510(k) clearance on 1980-03-05, under 510(k) number K800300.

Who is the listed applicant for AMERLEX T-4 RIA 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 T-4 RIA KIT?

The FDA product code for AMERLEX T-4 RIA KIT is CDX.

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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: CDX)

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.

K961490ELECSYS T4 ASSAYBoehringer Mannheim Corp.K954312ACTIVE THYROXINE RIADiagnostic Systems Laboratories, Inc.K943416DELFIA NEONATAL THYROXINE KITWallac OYK934384AXSYM(TM) TOTAL T4Abbott LaboratoriesK932980TOTAL T4 FPIA REAGENT SET/CALIBRATOR #T-1039,T-116Sigma Diagnostics, Inc.K933426STRATUS(R) TOTAL THYROXINE(T4) FLUOR ENZYME IMMUNOBaxter Diagnostics, 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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