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FDA 510(k)

LAN.0800Q/2800Q

K-Number: K895872 · 1989-10-17

ApplicantAmersham Corp.
Decision Date1989-10-17
Product CodeDBF
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

LAN.0800Q/2800Q is the device name listed in this FDA 510(k) record. The listed applicant is Amersham Corp.. It received FDA 510(k) clearance on 1989-10-17 under 510(k) number K895872. The device is classified under product code DBF. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LAN.0800Q/2800Q?

LAN.0800Q/2800Q is a medical device that received FDA 510(k) clearance on 1989-10-17. The listed applicant is Amersham Corp.. The 510(k) number is K895872.

When did LAN.0800Q/2800Q receive FDA 510(k) clearance?

LAN.0800Q/2800Q received FDA 510(k) clearance on 1989-10-17, under 510(k) number K895872.

Who is the listed applicant for LAN.0800Q/2800Q?

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 LAN.0800Q/2800Q?

The FDA product code for LAN.0800Q/2800Q is DBF.

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: DBF)

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.

K193650LIAISON FerritinDiaSorin, Inc.K191562Yumizen C1200 Ferritin, Yumizen C1200 Transferrin, Yumizen C1200 Rheumatoid FactorHORIBA ABX SASK171642Atellica IM Ferritin AssaySiemens Healthcare Diagnostics, Inc.K121232K-ASSAY (R) FERRITIN REAGENT, K-ASSAY (R) FERRITIN CALIBRATORKamiya Biomedical CompanyK110736ADVIA CHEMISTRY FERRITIN (FRT) METHODSiemens Healthcare Diagnostics, Inc.K100538TINA-QUANT FERRITIN GEN. 4Roche Diagnostics

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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