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FDA 510(k)

AMERLITE T3U ASSAY LAN.0004/1004/2004, 240/480/144

K-Number: K874362 · 1988-02-18

ApplicantAmersham Corp.
Decision Date1988-02-18
Product CodeKHQ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

AMERLITE T3U ASSAY LAN.0004/1004/2004, 240/480/144 is the device name listed in this FDA 510(k) record. The listed applicant is Amersham Corp.. It received FDA 510(k) clearance on 1988-02-18 under 510(k) number K874362. The device is classified under product code KHQ. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AMERLITE T3U ASSAY LAN.0004/1004/2004, 240/480/144?

AMERLITE T3U ASSAY LAN.0004/1004/2004, 240/480/144 is a medical device that received FDA 510(k) clearance on 1988-02-18. The listed applicant is Amersham Corp.. The 510(k) number is K874362.

When did AMERLITE T3U ASSAY LAN.0004/1004/2004, 240/480/144 receive FDA 510(k) clearance?

AMERLITE T3U ASSAY LAN.0004/1004/2004, 240/480/144 received FDA 510(k) clearance on 1988-02-18, under 510(k) number K874362.

Who is the listed applicant for AMERLITE T3U ASSAY LAN.0004/1004/2004, 240/480/144?

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 T3U ASSAY LAN.0004/1004/2004, 240/480/144?

The FDA product code for AMERLITE T3U ASSAY LAN.0004/1004/2004, 240/480/144 is KHQ.

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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: KHQ)

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.

K981375ACE T UPTAKE REAGENT TU CALIBRATORSSchiapparelli Biosystems, Inc.K980088T-UPTAKE MICROPLATE EIAMonobindK970539CHIRON DIAGNOSTICS ACS:180TU PChiron Diagnostics Corp.K964308VITROS IMMUNODIAGNOSTICS PRODUCTS T3 UPTAKE REAGENT PACK (GEM.1025) AND T3 UPTAKE CALIBRATORS (GEM.C025)Johnson & Johnson Clinical Diagnostics, Inc.K961488ELECSYS T-UPTAKE ASSAYBoehringer Mannheim Corp.K954807CEDIA T UPTAKE ASSAYBoehringer Mannheim Corp.

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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