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FDA 510(k)

PHASE II FSH KIT

K-Number: K883279 · 1988-09-09

ApplicantVitek Systems, Inc.
Decision Date1988-09-09
Product CodeCGJ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

PHASE II FSH KIT is the device name listed in this FDA 510(k) record. The listed applicant is Vitek Systems, Inc.. It received FDA 510(k) clearance on 1988-09-09 under 510(k) number K883279. 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 PHASE II FSH KIT?

PHASE II FSH KIT is a medical device that received FDA 510(k) clearance on 1988-09-09. The listed applicant is Vitek Systems, Inc.. The 510(k) number is K883279.

When did PHASE II FSH KIT receive FDA 510(k) clearance?

PHASE II FSH KIT received FDA 510(k) clearance on 1988-09-09, under 510(k) number K883279.

Who is the listed applicant for PHASE II FSH KIT?

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

What is the FDA product code for PHASE II FSH KIT?

The FDA product code for PHASE II FSH KIT is CGJ.

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Other records listing Vitek Systems, Inc. as applicant

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K920661VIDAS CMV IGG ASSAYK921302VITEK IMMUNODIAGNOSTIC ASSAY SYSTEMK921176VITEK IMMUNODIAGNOSTIC ASSAY SYSTEMK920952VITEK IMMUNODIAG ASSAY SYST(VIDAS) FERRITINE ASSAYK915884VIDAS CHLAMYDIA ASSAY, MODIFICATIONK905211VIDAS CLOSTRIDIUM DIFFICILE TOXIN A (CDA) ASSAY

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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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