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FDA 510(k)

SEALITE SCIENCES, INC. AQUALITE LH

K-Number: K964925 · 1997-01-22

ApplicantSealite Sciences, Inc.
Decision Date1997-01-22
Product CodeCEP
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

SEALITE SCIENCES, INC. AQUALITE LH 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 1997-01-22 under 510(k) number K964925. The device is classified under product code CEP. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SEALITE SCIENCES, INC. AQUALITE LH?

SEALITE SCIENCES, INC. AQUALITE LH is a medical device that received FDA 510(k) clearance on 1997-01-22. The listed applicant is Sealite Sciences, Inc.. The 510(k) number is K964925.

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

SEALITE SCIENCES, INC. AQUALITE LH received FDA 510(k) clearance on 1997-01-22, under 510(k) number K964925.

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

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 LH?

The FDA product code for SEALITE SCIENCES, INC. AQUALITE LH is CEP.

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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 PTHK970188SEALITE SCIENCES, INC. AQUALITE PROLACTINK970085SEALITE SCIENCES AQUALITE FSH

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Related Devices (Code: CEP)

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.

K013582MAYBE?MOM MINI OVULATION MICROSCOPEMaybe?MomK022829INSTANT-VIEW LH OVULATION PREDICTING TESTAlfa Scientific Designs, Inc.K021409AT HOME OVULATION TEST, MODEL 9032Phamatech, Inc.K013874CLEARPLANE EASY OVULATION TESTUnipath , Ltd.K013323TCI-31 LIFELONG OVULATION TESTERTci New YorkK012252QUIK-CHECK OVULATION PREDICTORACON 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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