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FDA 510(k)

OPUS FSH

K-Number: K911409 · 1991-04-16

ApplicantPb Diagnostic Systems, Inc.
Decision Date1991-04-16
Product CodeCGJ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

OPUS FSH is the device name listed in this FDA 510(k) record. The listed applicant is Pb Diagnostic Systems, Inc.. It received FDA 510(k) clearance on 1991-04-16 under 510(k) number K911409. 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 OPUS FSH?

OPUS FSH is a medical device that received FDA 510(k) clearance on 1991-04-16. The listed applicant is Pb Diagnostic Systems, Inc.. The 510(k) number is K911409.

When did OPUS FSH receive FDA 510(k) clearance?

OPUS FSH received FDA 510(k) clearance on 1991-04-16, under 510(k) number K911409.

Who is the listed applicant for OPUS FSH?

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

What is the FDA product code for OPUS FSH?

The FDA product code for OPUS FSH is CGJ.

Other records listing Pb Diagnostic Systems, 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.

K940507OPUS FT4 TEST SYSTEMK934762OPUS PROCAINAMIDE TEST SYSTEMK933389OPUS CMV-GK934137OPUS(R) SEROLOGY CONTROLS, MODIFICATIONK935229OPUS DIGITOXINK934705OPUS NAPA

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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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