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FDA 510(k)

PROLACTIN (PRL) HORMONE MICROPLATE ELISA

K-Number: K971921 · 1997-06-24

ApplicantMonobind
Decision Date1997-06-24
Product CodeCFT
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

PROLACTIN (PRL) HORMONE MICROPLATE ELISA is the device name listed in this FDA 510(k) record. The listed applicant is Monobind. It received FDA 510(k) clearance on 1997-06-24 under 510(k) number K971921. 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 PROLACTIN (PRL) HORMONE MICROPLATE ELISA?

PROLACTIN (PRL) HORMONE MICROPLATE ELISA is a medical device that received FDA 510(k) clearance on 1997-06-24. The listed applicant is Monobind. The 510(k) number is K971921.

When did PROLACTIN (PRL) HORMONE MICROPLATE ELISA receive FDA 510(k) clearance?

PROLACTIN (PRL) HORMONE MICROPLATE ELISA received FDA 510(k) clearance on 1997-06-24, under 510(k) number K971921.

Who is the listed applicant for PROLACTIN (PRL) HORMONE MICROPLATE ELISA?

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

What is the FDA product code for PROLACTIN (PRL) HORMONE MICROPLATE ELISA?

The FDA product code for PROLACTIN (PRL) HORMONE MICROPLATE ELISA is CFT.

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Other records listing Monobind 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.

K030860ACCUBIND NEONATAL T4 MICROPLATE EIA, MODEL 2625-300K020548FREE T4 (THYTOXINE) MICROPLATE EIA TEST MODELS # 1225-300K980088T-UPTAKE MICROPLATE EIAK972720FOLLICLE STIMULATING HORMONE (FSH) MICROPLATE ELISA (425-300)K971835ANTI-THYROGLOBULIN (TG) MICROPLATE ELISAK971834ANTI-THYROID PEROXIDASE (TPO) MICROPLATE ELISA

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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.

K970281VITROS 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.K954680ACCESS PROLACTIN ASSAY (MODIFICATION)Bio-Rad 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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