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FDA 510(k)

SEALITE SCIENCES INC.

K-Number: K941983 · 1994-08-18

ApplicantSealite Sciences, Inc.
Decision Date1994-08-18
Product CodeDHA
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

SEALITE SCIENCES INC. 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 1994-08-18 under 510(k) number K941983. The device is classified under product code DHA. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SEALITE SCIENCES INC.?

SEALITE SCIENCES INC. is a medical device that received FDA 510(k) clearance on 1994-08-18. The listed applicant is Sealite Sciences, Inc.. The 510(k) number is K941983.

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

SEALITE SCIENCES INC. received FDA 510(k) clearance on 1994-08-18, under 510(k) number K941983.

Who is the listed applicant for SEALITE SCIENCES INC.?

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.?

The FDA product code for SEALITE SCIENCES INC. is DHA.

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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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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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