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FDA 510(k)

PROLACTIN MAIACLONE IMMUNORADIO. KIT, MAG SOL PHA

K-Number: K873400 · 1987-09-25

ApplicantSerono Diagnostics, Inc.
Decision Date1987-09-25
Product CodeCFT
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

PROLACTIN MAIACLONE IMMUNORADIO. KIT, MAG SOL PHA is the device name listed in this FDA 510(k) record. The listed applicant is Serono Diagnostics, Inc.. It received FDA 510(k) clearance on 1987-09-25 under 510(k) number K873400. 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 MAIACLONE IMMUNORADIO. KIT, MAG SOL PHA?

PROLACTIN MAIACLONE IMMUNORADIO. KIT, MAG SOL PHA is a medical device that received FDA 510(k) clearance on 1987-09-25. The listed applicant is Serono Diagnostics, Inc.. The 510(k) number is K873400.

When did PROLACTIN MAIACLONE IMMUNORADIO. KIT, MAG SOL PHA receive FDA 510(k) clearance?

PROLACTIN MAIACLONE IMMUNORADIO. KIT, MAG SOL PHA received FDA 510(k) clearance on 1987-09-25, under 510(k) number K873400.

Who is the listed applicant for PROLACTIN MAIACLONE IMMUNORADIO. KIT, MAG SOL PHA?

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

What is the FDA product code for PROLACTIN MAIACLONE IMMUNORADIO. KIT, MAG SOL PHA?

The FDA product code for PROLACTIN MAIACLONE IMMUNORADIO. KIT, MAG SOL PHA is CFT.

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Other records listing Serono Diagnostics, 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.

K953598SERIES 9100 PLUS AUTOMATED DIFFERENTIAL HEMATOLOGY ANALYZERSK942051SR1 DHEA-S ENZYME IMMUNOASSAYK883085T3 UPTAKE SEROZYME ENZYME IMMUNO KT/MAG SOLID PHASK882340LH SEROZYME IMMUNOENZYMETRIC ASSAY KIT,MAG SOL PHAK880388T3 SEROZYME ENZYMEIMMUNOASSAY KIT, MAG SOLID PHASEK874866T4 SEROZYME ENZYMEIMMUNOASSAY KIT/MAG. SOLID PHASE

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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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