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FDA 510(k)

AMERLITE TSH-60 ASSAY PRODUCT CODE: LAN. 0008/2008

K-Number: K904666 · 1990-11-02

ApplicantAmersham Corp.
Decision Date1990-11-02
Product CodeJLW
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

AMERLITE TSH-60 ASSAY PRODUCT CODE: LAN. 0008/2008 is the device name listed in this FDA 510(k) record. The listed applicant is Amersham Corp.. It received FDA 510(k) clearance on 1990-11-02 under 510(k) number K904666. The device is classified under product code JLW. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AMERLITE TSH-60 ASSAY PRODUCT CODE: LAN. 0008/2008?

AMERLITE TSH-60 ASSAY PRODUCT CODE: LAN. 0008/2008 is a medical device that received FDA 510(k) clearance on 1990-11-02. The listed applicant is Amersham Corp.. The 510(k) number is K904666.

When did AMERLITE TSH-60 ASSAY PRODUCT CODE: LAN. 0008/2008 receive FDA 510(k) clearance?

AMERLITE TSH-60 ASSAY PRODUCT CODE: LAN. 0008/2008 received FDA 510(k) clearance on 1990-11-02, under 510(k) number K904666.

Who is the listed applicant for AMERLITE TSH-60 ASSAY PRODUCT CODE: LAN. 0008/2008?

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 TSH-60 ASSAY PRODUCT CODE: LAN. 0008/2008?

The FDA product code for AMERLITE TSH-60 ASSAY PRODUCT CODE: LAN. 0008/2008 is JLW.

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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 ASSAYK902760AMERSHAM TSH CONTROL SERAK901857GADOLINIUM-153 BONE DENSITOMETER (GDC.10413)K901854GADOLINIUM-153 BONE DENSITOMETER (GDC.10411/10412)

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Related Devices (Code: JLW)

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.

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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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