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FDA 510(k)

AMERLITE TSH ASSAY, LAN.0001/2001 240 & 144 KIT

K-Number: K882907 · 1988-09-22

ApplicantAmersham Corp.
Decision Date1988-09-22
Product CodeJLW
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

AMERLITE TSH ASSAY, LAN.0001/2001 240 & 144 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 1988-09-22 under 510(k) number K882907. 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 ASSAY, LAN.0001/2001 240 & 144 KIT?

AMERLITE TSH ASSAY, LAN.0001/2001 240 & 144 KIT is a medical device that received FDA 510(k) clearance on 1988-09-22. The listed applicant is Amersham Corp.. The 510(k) number is K882907.

When did AMERLITE TSH ASSAY, LAN.0001/2001 240 & 144 KIT receive FDA 510(k) clearance?

AMERLITE TSH ASSAY, LAN.0001/2001 240 & 144 KIT received FDA 510(k) clearance on 1988-09-22, under 510(k) number K882907.

Who is the listed applicant for AMERLITE TSH ASSAY, LAN.0001/2001 240 & 144 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 AMERLITE TSH ASSAY, LAN.0001/2001 240 & 144 KIT?

The FDA product code for AMERLITE TSH ASSAY, LAN.0001/2001 240 & 144 KIT 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 ASSAYK904666AMERLITE TSH-60 ASSAY PRODUCT CODE: LAN. 0008/2008K902760AMERSHAM TSH CONTROL SERAK901832GADOLINIUM-153 BONE DENSITOMETER SOURCES GDC.10415

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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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