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FDA 510(k)

ELISA TUBE PROLACTIN TEST KIT

K-Number: K920921 · 1992-04-08

ApplicantBio Clinic Co.
Decision Date1992-04-08
Product CodeCFT
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ELISA TUBE PROLACTIN TEST KIT is the device name listed in this FDA 510(k) record. The listed applicant is Bio Clinic Co.. It received FDA 510(k) clearance on 1992-04-08 under 510(k) number K920921. 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 ELISA TUBE PROLACTIN TEST KIT?

ELISA TUBE PROLACTIN TEST KIT is a medical device that received FDA 510(k) clearance on 1992-04-08. The listed applicant is Bio Clinic Co.. The 510(k) number is K920921.

When did ELISA TUBE PROLACTIN TEST KIT receive FDA 510(k) clearance?

ELISA TUBE PROLACTIN TEST KIT received FDA 510(k) clearance on 1992-04-08, under 510(k) number K920921.

Who is the listed applicant for ELISA TUBE PROLACTIN TEST KIT?

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

What is the FDA product code for ELISA TUBE PROLACTIN TEST KIT?

The FDA product code for ELISA TUBE PROLACTIN TEST KIT is CFT.

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Other records listing Bio Clinic Co. 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.

K930791AMERICAN POWER CONVERSIONS, BACK-UPS 600K932480PRISMK926189ORTHODERM CONSUMMATE AIR THERAPY BED W/SCALEK921958ELISA TUBE TSH TESTK922140ORTHODERM CONVERTIBLE IIK921212MIRCO ELISA HPL TEST KIT

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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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