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FDA 510(k)

PROLACTIN SYSTEM BY RIA

K-Number: K851330 · 1985-04-29

ApplicantAmerican Bioclinical, Inc.
Decision Date1985-04-29
Product CodeCFT
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

PROLACTIN SYSTEM BY RIA is the device name listed in this FDA 510(k) record. The listed applicant is American Bioclinical, Inc.. It received FDA 510(k) clearance on 1985-04-29 under 510(k) number K851330. 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 SYSTEM BY RIA?

PROLACTIN SYSTEM BY RIA is a medical device that received FDA 510(k) clearance on 1985-04-29. The listed applicant is American Bioclinical, Inc.. The 510(k) number is K851330.

When did PROLACTIN SYSTEM BY RIA receive FDA 510(k) clearance?

PROLACTIN SYSTEM BY RIA received FDA 510(k) clearance on 1985-04-29, under 510(k) number K851330.

Who is the listed applicant for PROLACTIN SYSTEM BY RIA?

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

What is the FDA product code for PROLACTIN SYSTEM BY RIA?

The FDA product code for PROLACTIN SYSTEM BY RIA is CFT.

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Other records listing American Bioclinical, 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.

K852939CORTISOL SYSTEM BY EIAK852437VISUAL SERUM/URINE HCG COMBO KITK852376SIMULTANEOUS LH/FSH SYSTEM BY RIA

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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