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FDA 510(k)

AMERLEX-M SPECIFIC ESTROL(UNCONJUGATED) RIA KIT

K-Number: K912733 · 1991-07-22

ApplicantAmersham Corp.
Decision Date1991-07-22
Product CodeCIG
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

AMERLEX-M SPECIFIC ESTROL(UNCONJUGATED) RIA KIT is the device name listed in this FDA 510(k) record. The listed applicant is Amersham Corp.. It received FDA 510(k) clearance on 1991-07-22 under 510(k) number K912733. The device is classified under product code CIG. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AMERLEX-M SPECIFIC ESTROL(UNCONJUGATED) RIA KIT?

AMERLEX-M SPECIFIC ESTROL(UNCONJUGATED) RIA KIT is a medical device that received FDA 510(k) clearance on 1991-07-22. The listed applicant is Amersham Corp.. The 510(k) number is K912733.

When did AMERLEX-M SPECIFIC ESTROL(UNCONJUGATED) RIA KIT receive FDA 510(k) clearance?

AMERLEX-M SPECIFIC ESTROL(UNCONJUGATED) RIA KIT received FDA 510(k) clearance on 1991-07-22, under 510(k) number K912733.

Who is the listed applicant for AMERLEX-M SPECIFIC ESTROL(UNCONJUGATED) RIA KIT?

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 AMERLEX-M SPECIFIC ESTROL(UNCONJUGATED) RIA KIT?

The FDA product code for AMERLEX-M SPECIFIC ESTROL(UNCONJUGATED) RIA KIT is CIG.

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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.0086/2086K912766AMERLITE CK-MB ASSAYK904666AMERLITE TSH-60 ASSAY PRODUCT CODE: LAN. 0008/2008K902760AMERSHAM TSH CONTROL SERAK901832GADOLINIUM-153 BONE DENSITOMETER SOURCES GDC.10415K901854GADOLINIUM-153 BONE DENSITOMETER (GDC.10411/10412)

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Related Devices (Code: CIG)

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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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