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FDA 510(k)

AMERLITE TT3 ASSAY, LAN.0003/2003 240/144 KIT

K-Number: K881373 · 1988-05-27

ApplicantAmersham Corp.
Decision Date1988-05-27
Product CodeCDP
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

AMERLITE TT3 ASSAY, LAN.0003/2003 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 1988-05-27 under 510(k) number K881373. The device is classified under product code CDP. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AMERLITE TT3 ASSAY, LAN.0003/2003 240/144 KIT?

AMERLITE TT3 ASSAY, LAN.0003/2003 240/144 KIT is a medical device that received FDA 510(k) clearance on 1988-05-27. The listed applicant is Amersham Corp.. The 510(k) number is K881373.

When did AMERLITE TT3 ASSAY, LAN.0003/2003 240/144 KIT receive FDA 510(k) clearance?

AMERLITE TT3 ASSAY, LAN.0003/2003 240/144 KIT received FDA 510(k) clearance on 1988-05-27, under 510(k) number K881373.

Who is the listed applicant for AMERLITE TT3 ASSAY, LAN.0003/2003 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 TT3 ASSAY, LAN.0003/2003 240/144 KIT?

The FDA product code for AMERLITE TT3 ASSAY, LAN.0003/2003 240/144 KIT is CDP.

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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: CDP)

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.

K001607REPROBEAD T3 ENZYME IMMUNOASSAY REAGENT KIT (CATALOG# 104)Repromedix Corp.K991692CHIRON DIAGNOSTICS ACS: 180 FT3Chiron Diagnostics Corp.K991311TOTAL T3 ENZYME IMMUNOASSAY TEST KIT, MODEL BC-1005Biocheck, Inc.K991252AIA-PACK FT3 ASSAYTosoh Medics, Inc.K981824OPTICOAT T3 EIA KITBiotecx Laboratories, Inc.K983434ABBOTT ARCHITECT TOTAL T3Abbott Laboratories

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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