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FDA 510(k)

ISOLAB'S T4 TEST KIT

K-Number: K951014 · 1996-10-18

ApplicantIsolab, Inc.
Decision Date1996-10-18
Product CodeKLI
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ISOLAB'S T4 TEST KIT is the device name listed in this FDA 510(k) record. The listed applicant is Isolab, Inc.. It received FDA 510(k) clearance on 1996-10-18 under 510(k) number K951014. 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 ISOLAB'S T4 TEST KIT?

ISOLAB'S T4 TEST KIT is a medical device that received FDA 510(k) clearance on 1996-10-18. The listed applicant is Isolab, Inc.. The 510(k) number is K951014.

When did ISOLAB'S T4 TEST KIT receive FDA 510(k) clearance?

ISOLAB'S T4 TEST KIT received FDA 510(k) clearance on 1996-10-18, under 510(k) number K951014.

Who is the listed applicant for ISOLAB'S T4 TEST KIT?

The FDA 510(k) record lists Isolab, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ISOLAB'S T4 TEST KIT?

The FDA product code for ISOLAB'S T4 TEST KIT is KLI.

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Other records listing Isolab, Inc. 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.

K950481NEONATAL CHEMISTRY SYSTEM, GALACTOSE TEST KITK943547PHENYLALANINE TEST KITK950803ISOLAB'S GALACTOSE-1-PHOSPHATE URIDYL TRANFERASE TEST KITS 800, 4000 SAMPLEK950415FLUOROSCAN NEONATALK942222QUIK-SEP QUANTITIVE HEMOGLOBIN S CONTROLSK942276QUIK-SEP QUANTITATIVE HEMOGLOBIN S ASSAY

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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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