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FDA 510(k)

AMERLEX T-3 RIA KIT

K-Number: K800374 · 1980-03-12

ApplicantAmersham Corp.
Decision Date1980-03-12
Product CodeCDP
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

AMERLEX T-3 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 1980-03-12 under 510(k) number K800374. The device is classified under product code CDP. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AMERLEX T-3 RIA KIT?

AMERLEX T-3 RIA KIT is a medical device that received FDA 510(k) clearance on 1980-03-12. The listed applicant is Amersham Corp.. The 510(k) number is K800374.

When did AMERLEX T-3 RIA KIT receive FDA 510(k) clearance?

AMERLEX T-3 RIA KIT received FDA 510(k) clearance on 1980-03-12, under 510(k) number K800374.

Who is the listed applicant for AMERLEX T-3 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-3 RIA KIT?

The FDA product code for AMERLEX T-3 RIA KIT is CDP.

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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: CDP)

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.

K001607REPROBEAD T3 ENZYME IMMUNOASSAY REAGENT KIT (CATALOG# 104)Repromedix Corp.K991692CHIRON DIAGNOSTICS ACS: 180 FT3Chiron Diagnostics Corp.K991311TOTAL T3 ENZYME IMMUNOASSAY TEST KIT, MODEL BC-1005Biocheck, Inc.K991252AIA-PACK FT3 ASSAYTosoh Medics, Inc.K981824OPTICOAT T3 EIA KITBiotecx Laboratories, Inc.K983439ABBOTT ARCHITECT FREE T3Abbott Laboratories

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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