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FDA 510(k)

AMERLITE PROLACTIN ASSAY, LAN.0078/2078(240/144)

K-Number: K883878 · 1988-11-01

ApplicantAmersham Corp.
Decision Date1988-11-01
Product CodeCFT
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

AMERLITE PROLACTIN ASSAY, LAN.0078/2078(240/144) is the device name listed in this FDA 510(k) record. The listed applicant is Amersham Corp.. It received FDA 510(k) clearance on 1988-11-01 under 510(k) number K883878. The device is classified under product code CFT. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AMERLITE PROLACTIN ASSAY, LAN.0078/2078(240/144)?

AMERLITE PROLACTIN ASSAY, LAN.0078/2078(240/144) is a medical device that received FDA 510(k) clearance on 1988-11-01. The listed applicant is Amersham Corp.. The 510(k) number is K883878.

When did AMERLITE PROLACTIN ASSAY, LAN.0078/2078(240/144) receive FDA 510(k) clearance?

AMERLITE PROLACTIN ASSAY, LAN.0078/2078(240/144) received FDA 510(k) clearance on 1988-11-01, under 510(k) number K883878.

Who is the listed applicant for AMERLITE PROLACTIN ASSAY, LAN.0078/2078(240/144)?

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 PROLACTIN ASSAY, LAN.0078/2078(240/144)?

The FDA product code for AMERLITE PROLACTIN ASSAY, LAN.0078/2078(240/144) is CFT.

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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: CFT)

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.

K971921PROLACTIN (PRL) HORMONE MICROPLATE ELISAMonobindK970281VITROS IMMUNODIAGNOSTIC PRODUCTS PROLACTIN REAGENT PACK/CALIBRATORSJohnson & Johnson Clinical Diagnostics, Inc.K970188SEALITE SCIENCES, INC. AQUALITE PROLACTINSealite Sciences, Inc.K964748ELECSYS PROLACTIN ASSAYBoehringer Mannheim Corp.K960561DSL ACTIVE PROLACTIN ELISA MODEL 10-4500Diagnostic Systems Laboratories, Inc.K960060DSL ACTIVE PROLACTIN IRMADiagnostic Systems Laboratories, 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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