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FDA 510(k)

SR1 PROLACTIN (PRL IMMUNOENZYMETRIC ASSAY

K-Number: K895380 · 1989-10-17

ApplicantSerono-Baker Diagnostics, Inc.
Decision Date1989-10-17
Product CodeCFT
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

SR1 PROLACTIN (PRL IMMUNOENZYMETRIC ASSAY is the device name listed in this FDA 510(k) record. The listed applicant is Serono-Baker Diagnostics, Inc.. It received FDA 510(k) clearance on 1989-10-17 under 510(k) number K895380. 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 SR1 PROLACTIN (PRL IMMUNOENZYMETRIC ASSAY?

SR1 PROLACTIN (PRL IMMUNOENZYMETRIC ASSAY is a medical device that received FDA 510(k) clearance on 1989-10-17. The listed applicant is Serono-Baker Diagnostics, Inc.. The 510(k) number is K895380.

When did SR1 PROLACTIN (PRL IMMUNOENZYMETRIC ASSAY receive FDA 510(k) clearance?

SR1 PROLACTIN (PRL IMMUNOENZYMETRIC ASSAY received FDA 510(k) clearance on 1989-10-17, under 510(k) number K895380.

Who is the listed applicant for SR1 PROLACTIN (PRL IMMUNOENZYMETRIC ASSAY?

The FDA 510(k) record lists Serono-Baker Diagnostics, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SR1 PROLACTIN (PRL IMMUNOENZYMETRIC ASSAY?

The FDA product code for SR1 PROLACTIN (PRL IMMUNOENZYMETRIC ASSAY 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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