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FDA 510(k)

LACTI-QUANT

K-Number: K801849 · 1980-09-16

ApplicantNuclear Medical Laboratories, Inc.
Decision Date1980-09-16
Product CodeCFT
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

LACTI-QUANT is the device name listed in this FDA 510(k) record. The listed applicant is Nuclear Medical Laboratories, Inc.. It received FDA 510(k) clearance on 1980-09-16 under 510(k) number K801849. 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 LACTI-QUANT?

LACTI-QUANT is a medical device that received FDA 510(k) clearance on 1980-09-16. The listed applicant is Nuclear Medical Laboratories, Inc.. The 510(k) number is K801849.

When did LACTI-QUANT receive FDA 510(k) clearance?

LACTI-QUANT received FDA 510(k) clearance on 1980-09-16, under 510(k) number K801849.

Who is the listed applicant for LACTI-QUANT?

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

What is the FDA product code for LACTI-QUANT?

The FDA product code for LACTI-QUANT is CFT.

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Other records listing Nuclear Medical Laboratories, 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.

K852438NML TSH IRMAK844583TSH-STATK840466NML CORTISOL RIAK840589TRI-TUBE RIAK832892MODIFIED CHORIO-SHUREK832002NML-5010/5020 MULTI-DETECTOR SYSTEM

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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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