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FDA 510(k)

AMERLITE TT4 ASSAY (240/480/144 TEST KITS)

K-Number: K873976 · 1987-11-05

ApplicantAmersham Corp.
Decision Date1987-11-05
Product CodeKLI
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

AMERLITE TT4 ASSAY (240/480/144 TEST KITS) is the device name listed in this FDA 510(k) record. The listed applicant is Amersham Corp.. It received FDA 510(k) clearance on 1987-11-05 under 510(k) number K873976. The device is classified under product code KLI. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AMERLITE TT4 ASSAY (240/480/144 TEST KITS)?

AMERLITE TT4 ASSAY (240/480/144 TEST KITS) is a medical device that received FDA 510(k) clearance on 1987-11-05. The listed applicant is Amersham Corp.. The 510(k) number is K873976.

When did AMERLITE TT4 ASSAY (240/480/144 TEST KITS) receive FDA 510(k) clearance?

AMERLITE TT4 ASSAY (240/480/144 TEST KITS) received FDA 510(k) clearance on 1987-11-05, under 510(k) number K873976.

Who is the listed applicant for AMERLITE TT4 ASSAY (240/480/144 TEST KITS)?

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 TT4 ASSAY (240/480/144 TEST KITS)?

The FDA product code for AMERLITE TT4 ASSAY (240/480/144 TEST KITS) is KLI.

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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

View all 94 devices →

Related Devices (Code: KLI)

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.

K160495VITROS® Automation SolutionsOrtho-Clinical Diagnostics, Inc.K131515ACE -GT REAGENT; ACE LIPASE RAGENT; ACE T4 REAGENTAlfa WassermannK103484GSP NEONATAL THYROXINE (T4)Wallac Oy, A Subsidiary of Perkinelmer, Inc.K082638ADVIA CENTAUR SYSTEM WITH STREAMLAB ANALYTICAL WORKCELLSiemens Healthcare Diagnostics, Inc.K030860ACCUBIND NEONATAL T4 MICROPLATE EIA, MODEL 2625-300MonobindK023369ACCESS TOTAL T4 ASSAYBeckman Coulter, 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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