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FDA 510(k)

AMERLITE ESTRADIOL-60 ASSAY LAN.0081/2081

K-Number: K896270 · 1989-12-12

ApplicantAmersham Corp.
Decision Date1989-12-12
Product CodeCHP
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

AMERLITE ESTRADIOL-60 ASSAY LAN.0081/2081 is the device name listed in this FDA 510(k) record. The listed applicant is Amersham Corp.. It received FDA 510(k) clearance on 1989-12-12 under 510(k) number K896270. The device is classified under product code CHP. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AMERLITE ESTRADIOL-60 ASSAY LAN.0081/2081?

AMERLITE ESTRADIOL-60 ASSAY LAN.0081/2081 is a medical device that received FDA 510(k) clearance on 1989-12-12. The listed applicant is Amersham Corp.. The 510(k) number is K896270.

When did AMERLITE ESTRADIOL-60 ASSAY LAN.0081/2081 receive FDA 510(k) clearance?

AMERLITE ESTRADIOL-60 ASSAY LAN.0081/2081 received FDA 510(k) clearance on 1989-12-12, under 510(k) number K896270.

Who is the listed applicant for AMERLITE ESTRADIOL-60 ASSAY LAN.0081/2081?

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 ESTRADIOL-60 ASSAY LAN.0081/2081?

The FDA product code for AMERLITE ESTRADIOL-60 ASSAY LAN.0081/2081 is CHP.

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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: CHP)

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.

K041349LUMINESCENT IMMUNOASSAY KIT FOR THE DETECTION OF ESTRADIOL IN SALIVA AND SERUMIbl GmbHK97390117 B-ESTRADIOL (ELISA)Kmi Diagnostics, Inc.K973743ACCESS ESTRADIOL REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZERBeckman Instruments, Inc.K970386ACS ESTADIOL-6 IIChiron Diagnostics Corp.K970643VITROS IMMUNODIAGNOSTICS PRODUCTS ESTRADIOL REAGENT PACK(GEM. 1050)/ESTRADIOL CALIBRATORS (GEM.C050)Johnson & Johnson Clinical Diagnostics, Inc.K970126ACCESS ESTRADIOL REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER (33550,33540,33545)Bio-Rad 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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