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FDA 510(k)

ABBOTT IMX PROLACTIN(MODIFICATION)

K-Number: K953656 · 1995-10-03

ApplicantAbbott Mfg., Inc.
Decision Date1995-10-03
Product CodeCFT
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ABBOTT IMX PROLACTIN(MODIFICATION) is the device name listed in this FDA 510(k) record. The listed applicant is Abbott Mfg., Inc.. It received FDA 510(k) clearance on 1995-10-03 under 510(k) number K953656. 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 ABBOTT IMX PROLACTIN(MODIFICATION)?

ABBOTT IMX PROLACTIN(MODIFICATION) is a medical device that received FDA 510(k) clearance on 1995-10-03. The listed applicant is Abbott Mfg., Inc.. The 510(k) number is K953656.

When did ABBOTT IMX PROLACTIN(MODIFICATION) receive FDA 510(k) clearance?

ABBOTT IMX PROLACTIN(MODIFICATION) received FDA 510(k) clearance on 1995-10-03, under 510(k) number K953656.

Who is the listed applicant for ABBOTT IMX PROLACTIN(MODIFICATION)?

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

What is the FDA product code for ABBOTT IMX PROLACTIN(MODIFICATION)?

The FDA product code for ABBOTT IMX PROLACTIN(MODIFICATION) is CFT.

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Other records listing Abbott Mfg., 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.

K981457ALBPK981232CAK981231CO2K965230ABBOTT LIFECARE STANDARD TUBING INFUSION PUMPK971293LIFESHIELD PRIMARY I.V. SET WITH BACKCHECK VALVEK953657ABBOTT AXSYM PROLACTIN(MODIFICATION)

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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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