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FDA 510(k)

AMERLITE DIGOXIN ASSAY, LAN.0700/2700, 240/144 KIT

K-Number: K880823 · 1988-05-31

ApplicantAmersham Corp.
Decision Date1988-05-31
Product CodeKXT
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

AMERLITE DIGOXIN ASSAY, LAN.0700/2700, 240/144 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 1988-05-31 under 510(k) number K880823. The device is classified under product code KXT. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AMERLITE DIGOXIN ASSAY, LAN.0700/2700, 240/144 KIT?

AMERLITE DIGOXIN ASSAY, LAN.0700/2700, 240/144 KIT is a medical device that received FDA 510(k) clearance on 1988-05-31. The listed applicant is Amersham Corp.. The 510(k) number is K880823.

When did AMERLITE DIGOXIN ASSAY, LAN.0700/2700, 240/144 KIT receive FDA 510(k) clearance?

AMERLITE DIGOXIN ASSAY, LAN.0700/2700, 240/144 KIT received FDA 510(k) clearance on 1988-05-31, under 510(k) number K880823.

Who is the listed applicant for AMERLITE DIGOXIN ASSAY, LAN.0700/2700, 240/144 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 AMERLITE DIGOXIN ASSAY, LAN.0700/2700, 240/144 KIT?

The FDA product code for AMERLITE DIGOXIN ASSAY, LAN.0700/2700, 240/144 KIT is KXT.

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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: KXT)

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.

K193397ADVIA Centaur® Digoxin assaySiemens Healthcare Diagnostics, Inc.K153301Elecsys Digoxin Immunoassay, Elecsys PreciControl Cardiac IIRoche DiagnosticsK102346RANDOX DIGOXIN ASSAYRandox Laboratories, Ltd.K093441DIMENSION VISTA LOCI DIGOXIN FLEX REAGENT CARTRIDGE (DIGXN), MODEL K6435Siemens Healthcare DiagnosticsK082953ARCHITECT IDIGOXIN AND ARCHITECT IDIGOXIN CALIBRATORS, MODELS 1P32-25 AND IP32-01Biokit, S.A.K061249AXSYM DIGOXIN IIIAbbott 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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