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FDA 510(k)

FSH QUIK RIA KIT

K-Number: K840230 · 1984-03-23

ApplicantPacific Biotech, Inc.
Decision Date1984-03-23
Product CodeCGJ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

FSH QUIK RIA KIT is the device name listed in this FDA 510(k) record. The listed applicant is Pacific Biotech, Inc.. It received FDA 510(k) clearance on 1984-03-23 under 510(k) number K840230. 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 FSH QUIK RIA KIT?

FSH QUIK RIA KIT is a medical device that received FDA 510(k) clearance on 1984-03-23. The listed applicant is Pacific Biotech, Inc.. The 510(k) number is K840230.

When did FSH QUIK RIA KIT receive FDA 510(k) clearance?

FSH QUIK RIA KIT received FDA 510(k) clearance on 1984-03-23, under 510(k) number K840230.

Who is the listed applicant for FSH QUIK RIA KIT?

The FDA 510(k) record lists Pacific Biotech, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for FSH QUIK RIA KIT?

The FDA product code for FSH QUIK RIA KIT is CGJ.

Other records listing Pacific Biotech, Inc. as applicant

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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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