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FDA 510(k)

PROLACTIN IRMA IMMUNOMAG

K-Number: K914107 · 1991-09-30

ApplicantPantex, Div. Bio-Analysis, Inc.
Decision Date1991-09-30
Product CodeCFT
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

PROLACTIN IRMA IMMUNOMAG is the device name listed in this FDA 510(k) record. The listed applicant is Pantex, Div. Bio-Analysis, Inc.. It received FDA 510(k) clearance on 1991-09-30 under 510(k) number K914107. 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 IRMA IMMUNOMAG?

PROLACTIN IRMA IMMUNOMAG is a medical device that received FDA 510(k) clearance on 1991-09-30. The listed applicant is Pantex, Div. Bio-Analysis, Inc.. The 510(k) number is K914107.

When did PROLACTIN IRMA IMMUNOMAG receive FDA 510(k) clearance?

PROLACTIN IRMA IMMUNOMAG received FDA 510(k) clearance on 1991-09-30, under 510(k) number K914107.

Who is the listed applicant for PROLACTIN IRMA IMMUNOMAG?

The FDA 510(k) record lists Pantex, Div. Bio-Analysis, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PROLACTIN IRMA IMMUNOMAG?

The FDA product code for PROLACTIN IRMA IMMUNOMAG is CFT.

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Other records listing Pantex, Div. Bio-Analysis, 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.

K102841PANTEX AM/PM SALIVARY CORTISOL ENZYME IMMUNOASSAYK942658NEOSCREEN ELISA TSHK912804FSH IRMA IMMUNOMAGK911839NEONATAL BLOOD SPOT TEST 17-HYDROXPROG RADIO KITK911050LH IRMA IMMUNOMAGK910717PANTEX IRMA LH 1251 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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