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FDA 510(k)

125 I PROLACTIN HORMONE RIA KIT

K-Number: K792166 · 1979-11-13

ApplicantDiagnostic Products Corp.
Decision Date1979-11-13
Product CodeCFT
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

125 I PROLACTIN HORMONE RIA KIT is the device name listed in this FDA 510(k) record. The listed applicant is Diagnostic Products Corp.. It received FDA 510(k) clearance on 1979-11-13 under 510(k) number K792166. 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 125 I PROLACTIN HORMONE RIA KIT?

125 I PROLACTIN HORMONE RIA KIT is a medical device that received FDA 510(k) clearance on 1979-11-13. The listed applicant is Diagnostic Products Corp.. The 510(k) number is K792166.

When did 125 I PROLACTIN HORMONE RIA KIT receive FDA 510(k) clearance?

125 I PROLACTIN HORMONE RIA KIT received FDA 510(k) clearance on 1979-11-13, under 510(k) number K792166.

Who is the listed applicant for 125 I PROLACTIN HORMONE RIA KIT?

The FDA 510(k) record lists Diagnostic Products Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for 125 I PROLACTIN HORMONE RIA KIT?

The FDA product code for 125 I PROLACTIN HORMONE RIA KIT is CFT.

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Other records listing Diagnostic Products Corp. 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.

K063045IMMULITE 2000, IMMULITE 2500 VANCOMYCINK034055IMMULITE 2500 CK-MB, 2500 MYOGLOBIN, 2500 STAT TROPONIN IK033234IMMULITE 2500 AUTOMATED IMMUNOASSAY ANALYZERK032881IMMULITE/IMMULITE 1000 TOTAL TESTOSTERONE AND IMMULITE 2000 TOTAL TESTOSTERONEK023152IMMULITE 2000 ALLERGEN-SPECIFIC IGEK023304IMMULITE/IMMULITE 1000 CALCITONIN, MODEL LKCL AND IMMULITE 2000 CALCITONIN, MODEL L2KCL

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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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