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FDA 510(k)

SEALITE SCIENCES AQUALITE FSH

K-Number: K970085 · 1997-02-14

ApplicantSealite Sciences, Inc.
Decision Date1997-02-14
Product CodeCGJ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

SEALITE SCIENCES AQUALITE FSH 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 1997-02-14 under 510(k) number K970085. The device is classified under product code CGJ. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SEALITE SCIENCES AQUALITE FSH?

SEALITE SCIENCES AQUALITE FSH is a medical device that received FDA 510(k) clearance on 1997-02-14. The listed applicant is Sealite Sciences, Inc.. The 510(k) number is K970085.

When did SEALITE SCIENCES AQUALITE FSH receive FDA 510(k) clearance?

SEALITE SCIENCES AQUALITE FSH received FDA 510(k) clearance on 1997-02-14, under 510(k) number K970085.

Who is the listed applicant for SEALITE SCIENCES AQUALITE FSH?

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 AQUALITE FSH?

The FDA product code for SEALITE SCIENCES AQUALITE FSH is CGJ.

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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 PROLACTINK964925SEALITE SCIENCES, INC. AQUALITE LH

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Related Devices (Code: CGJ)

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.

K052662ONE STEP FSH MENOPAUSAL TESTInd Diagnostic, Inc.K043599MOMENTS MENOPAUSE CHECK, MODEL 9113Phamatech, Inc.K041165FSH MENOPAUSE PREDICTOR TESTACON Laboratories, Inc.K040575PHARMATECH MENOPAUSE CHECK, MODELS 9111 AND 9112Phamatech, Inc.K030058EARLYDETECT MENOPAUSE TEST FOR FSHEarly Detect, Inc.K002450GENUA MENOPAUSE MONITOR TEST KITGenua 1944, 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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