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FDA 510(k)

SEALITE SCIENCE, INC. AQUALITE(R) LH

K-Number: K943188 · 1994-10-20

ApplicantSealite Sciences, Inc.
Decision Date1994-10-20
Product CodeCEP
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

SEALITE SCIENCE, INC. AQUALITE(R) 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 1994-10-20 under 510(k) number K943188. 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 SCIENCE, INC. AQUALITE(R) LH?

SEALITE SCIENCE, INC. AQUALITE(R) LH is a medical device that received FDA 510(k) clearance on 1994-10-20. The listed applicant is Sealite Sciences, Inc.. The 510(k) number is K943188.

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

SEALITE SCIENCE, INC. AQUALITE(R) LH received FDA 510(k) clearance on 1994-10-20, under 510(k) number K943188.

Who is the listed applicant for SEALITE SCIENCE, INC. AQUALITE(R) 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 SCIENCE, INC. AQUALITE(R) LH?

The FDA product code for SEALITE SCIENCE, INC. AQUALITE(R) 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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