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FDA 510(k)

GAMMA PROLACTIN RADIOIMMUNOASSAY KIT-

K-Number: K801020 · 1980-07-08

ApplicantTravenol Laboratories, S.A.
Decision Date1980-07-08
Product CodeCFT
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

GAMMA PROLACTIN RADIOIMMUNOASSAY KIT- is the device name listed in this FDA 510(k) record. The listed applicant is Travenol Laboratories, S.A.. It received FDA 510(k) clearance on 1980-07-08 under 510(k) number K801020. 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 GAMMA PROLACTIN RADIOIMMUNOASSAY KIT-?

GAMMA PROLACTIN RADIOIMMUNOASSAY KIT- is a medical device that received FDA 510(k) clearance on 1980-07-08. The listed applicant is Travenol Laboratories, S.A.. The 510(k) number is K801020.

When did GAMMA PROLACTIN RADIOIMMUNOASSAY KIT- receive FDA 510(k) clearance?

GAMMA PROLACTIN RADIOIMMUNOASSAY KIT- received FDA 510(k) clearance on 1980-07-08, under 510(k) number K801020.

Who is the listed applicant for GAMMA PROLACTIN RADIOIMMUNOASSAY KIT-?

The FDA 510(k) record lists Travenol Laboratories, S.A. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for GAMMA PROLACTIN RADIOIMMUNOASSAY KIT-?

The FDA product code for GAMMA PROLACTIN RADIOIMMUNOASSAY KIT- 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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