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FDA 510(k)

MEDIX BIOTECH THROXINE ENZYME IMMUNOASSAY TEST KIT

K-Number: K920712 · 1992-03-27

ApplicantMedix Biotech, Inc.
Decision Date1992-03-27
Product CodeKLI
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

MEDIX BIOTECH THROXINE ENZYME IMMUNOASSAY TEST KIT is the device name listed in this FDA 510(k) record. The listed applicant is Medix Biotech, Inc.. It received FDA 510(k) clearance on 1992-03-27 under 510(k) number K920712. 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 MEDIX BIOTECH THROXINE ENZYME IMMUNOASSAY TEST KIT?

MEDIX BIOTECH THROXINE ENZYME IMMUNOASSAY TEST KIT is a medical device that received FDA 510(k) clearance on 1992-03-27. The listed applicant is Medix Biotech, Inc.. The 510(k) number is K920712.

When did MEDIX BIOTECH THROXINE ENZYME IMMUNOASSAY TEST KIT receive FDA 510(k) clearance?

MEDIX BIOTECH THROXINE ENZYME IMMUNOASSAY TEST KIT received FDA 510(k) clearance on 1992-03-27, under 510(k) number K920712.

Who is the listed applicant for MEDIX BIOTECH THROXINE ENZYME IMMUNOASSAY TEST KIT?

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

What is the FDA product code for MEDIX BIOTECH THROXINE ENZYME IMMUNOASSAY TEST KIT?

The FDA product code for MEDIX BIOTECH THROXINE ENZYME IMMUNOASSAY TEST KIT is KLI.

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Other records listing Medix Biotech, 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.

K952873MEDIX BIOTECH STREP A ANTIGEN DETECTION TEST (MODIFICATION)K952319CONTRAST & RAPID HCG URINE/SERUM TSTK932482MEDIX BIOTECH BESTEST STREP A CAT. NO. BSF1010K932758MEDIX BIOTECH BESTEST HCG-URINE TEST KITK925436MEDIX BIOTECH TOTAL T3 ENZYME IMMUNOASSAY TEST KITK924259MEDIX BIOTECH BESTEST(TM) HCG-URINE, CAT# B1H0100

View all 39 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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