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FDA 510(k)

AQUALITE INTACT PTH

K-Number: K970483 · 1997-04-14

ApplicantSealite Sciences, Inc.
Decision Date1997-04-14
Product CodeCEW
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

AQUALITE INTACT PTH 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 1997-04-14 under 510(k) number K970483. The device is classified under product code CEW. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AQUALITE INTACT PTH?

AQUALITE INTACT PTH is a medical device that received FDA 510(k) clearance on 1997-04-14. The listed applicant is Sealite Sciences, Inc.. The 510(k) number is K970483.

When did AQUALITE INTACT PTH receive FDA 510(k) clearance?

AQUALITE INTACT PTH received FDA 510(k) clearance on 1997-04-14, under 510(k) number K970483.

Who is the listed applicant for AQUALITE INTACT PTH?

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 AQUALITE INTACT PTH?

The FDA product code for AQUALITE INTACT PTH is CEW.

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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 ASSAYK970188SEALITE SCIENCES, INC. AQUALITE PROLACTINK970085SEALITE SCIENCES AQUALITE FSHK964925SEALITE SCIENCES, INC. AQUALITE LH

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Related Devices (Code: CEW)

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.

K231927Elecsys PTH , Elecsys PTH STATRoche DiagnosticsK232791Access Intact PTHBeckman Coulter, Inc.K221197VITROS Immunodiagnostic Products Intact PTH II Reagent PackOrtho Clinical DiagnosticsK190702Lumipulse G whole PTHFujirebio Diagnostics,Inc.K163658ADVIA Centaur Intact Parathyroid Hormone (PTH) AssaySiemens Healthcare Diagnostics, Inc.K161158IDS-iSYS Intact PTHNImmunodiagnostic Systems , Ltd.

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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