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FDA 510(k)

SEALITE SCIENCES, INC. AQUALITE PROLACTIN

K-Number: K970188 · 1997-02-20

ApplicantSealite Sciences, Inc.
Decision Date1997-02-20
Product CodeCFT
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

SEALITE SCIENCES, INC. AQUALITE PROLACTIN is the device name listed in this FDA 510(k) record. The listed applicant is Sealite Sciences, Inc.. It received FDA 510(k) clearance on 1997-02-20 under 510(k) number K970188. 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 SEALITE SCIENCES, INC. AQUALITE PROLACTIN?

SEALITE SCIENCES, INC. AQUALITE PROLACTIN is a medical device that received FDA 510(k) clearance on 1997-02-20. The listed applicant is Sealite Sciences, Inc.. The 510(k) number is K970188.

When did SEALITE SCIENCES, INC. AQUALITE PROLACTIN receive FDA 510(k) clearance?

SEALITE SCIENCES, INC. AQUALITE PROLACTIN received FDA 510(k) clearance on 1997-02-20, under 510(k) number K970188.

Who is the listed applicant for SEALITE SCIENCES, INC. AQUALITE PROLACTIN?

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

What is the FDA product code for SEALITE SCIENCES, INC. AQUALITE PROLACTIN?

The FDA product code for SEALITE SCIENCES, INC. AQUALITE PROLACTIN is CFT.

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Other records listing Sealite Sciences, 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.

K974551SEALITE SCIENCES, INC. AQUALITE FREE T, ASSAYK972761SEALITE SCIENCES, INC. AQUALITE HUMAN GROWTH HORMONE ASSAYK970612SEALITE SCIENCES, INC. AQUALITE FERRITIN ASSAYK970483AQUALITE INTACT PTHK970085SEALITE SCIENCES AQUALITE FSHK964925SEALITE SCIENCES, INC. AQUALITE LH

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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.K964748ELECSYS PROLACTIN ASSAYBoehringer Mannheim Corp.K960561DSL ACTIVE PROLACTIN ELISA MODEL 10-4500Diagnostic Systems Laboratories, Inc.K960060DSL ACTIVE PROLACTIN IRMADiagnostic Systems Laboratories, Inc.K954680ACCESS PROLACTIN ASSAY (MODIFICATION)Bio-Rad 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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