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FDA 510(k)

MARRIA-HPRL RIA KIT

K-Number: K812112 · 1981-08-13

ApplicantIntl. Immunoassay Laboratories, Inc.
Decision Date1981-08-13
Product CodeCFT
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

MARRIA-HPRL RIA KIT is the device name listed in this FDA 510(k) record. The listed applicant is Intl. Immunoassay Laboratories, Inc.. It received FDA 510(k) clearance on 1981-08-13 under 510(k) number K812112. 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 MARRIA-HPRL RIA KIT?

MARRIA-HPRL RIA KIT is a medical device that received FDA 510(k) clearance on 1981-08-13. The listed applicant is Intl. Immunoassay Laboratories, Inc.. The 510(k) number is K812112.

When did MARRIA-HPRL RIA KIT receive FDA 510(k) clearance?

MARRIA-HPRL RIA KIT received FDA 510(k) clearance on 1981-08-13, under 510(k) number K812112.

Who is the listed applicant for MARRIA-HPRL RIA KIT?

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

What is the FDA product code for MARRIA-HPRL RIA KIT?

The FDA product code for MARRIA-HPRL RIA KIT is CFT.

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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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