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FDA 510(k)

MEDIX BIOTECH PROLACTIN ENZYME IMMUNO. TEST KIT

K-Number: K873355 · 1987-10-09

ApplicantMedix Biotech, Inc.
Decision Date1987-10-09
Product CodeCFT
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

MEDIX BIOTECH PROLACTIN ENZYME IMMUNO. 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 1987-10-09 under 510(k) number K873355. The device is classified under product code CFT. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MEDIX BIOTECH PROLACTIN ENZYME IMMUNO. TEST KIT?

MEDIX BIOTECH PROLACTIN ENZYME IMMUNO. TEST KIT is a medical device that received FDA 510(k) clearance on 1987-10-09. The listed applicant is Medix Biotech, Inc.. The 510(k) number is K873355.

When did MEDIX BIOTECH PROLACTIN ENZYME IMMUNO. TEST KIT receive FDA 510(k) clearance?

MEDIX BIOTECH PROLACTIN ENZYME IMMUNO. TEST KIT received FDA 510(k) clearance on 1987-10-09, under 510(k) number K873355.

Who is the listed applicant for MEDIX BIOTECH PROLACTIN ENZYME IMMUNO. 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 PROLACTIN ENZYME IMMUNO. TEST KIT?

The FDA product code for MEDIX BIOTECH PROLACTIN ENZYME IMMUNO. TEST KIT is CFT.

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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

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Related Devices (Code: CFT)

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.

K971921PROLACTIN (PRL) HORMONE MICROPLATE ELISAMonobindK970281VITROS IMMUNODIAGNOSTIC PRODUCTS PROLACTIN REAGENT PACK/CALIBRATORSJohnson & Johnson Clinical Diagnostics, Inc.K970188SEALITE SCIENCES, INC. AQUALITE PROLACTINSealite Sciences, Inc.K964748ELECSYS PROLACTIN ASSAYBoehringer Mannheim Corp.K960561DSL ACTIVE PROLACTIN ELISA MODEL 10-4500Diagnostic Systems Laboratories, Inc.K960060DSL ACTIVE PROLACTIN IRMADiagnostic Systems Laboratories, 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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