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FDA 510(k)

FSH ENZYME IMMUNOASSAY TEST KIT NO. MB-1057

K-Number: K881596 · 1988-05-27

ApplicantMedix Biotech, Inc.
Decision Date1988-05-27
Product CodeCGJ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

FSH ENZYME IMMUNOASSAY TEST KIT NO. MB-1057 is the device name listed in this FDA 510(k) record. The listed applicant is Medix Biotech, Inc.. It received FDA 510(k) clearance on 1988-05-27 under 510(k) number K881596. 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 ENZYME IMMUNOASSAY TEST KIT NO. MB-1057?

FSH ENZYME IMMUNOASSAY TEST KIT NO. MB-1057 is a medical device that received FDA 510(k) clearance on 1988-05-27. The listed applicant is Medix Biotech, Inc.. The 510(k) number is K881596.

When did FSH ENZYME IMMUNOASSAY TEST KIT NO. MB-1057 receive FDA 510(k) clearance?

FSH ENZYME IMMUNOASSAY TEST KIT NO. MB-1057 received FDA 510(k) clearance on 1988-05-27, under 510(k) number K881596.

Who is the listed applicant for FSH ENZYME IMMUNOASSAY TEST KIT NO. MB-1057?

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

What is the FDA product code for FSH ENZYME IMMUNOASSAY TEST KIT NO. MB-1057?

The FDA product code for FSH ENZYME IMMUNOASSAY TEST KIT NO. MB-1057 is CGJ.

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Other records listing Medix Biotech, 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.

K952873MEDIX BIOTECH STREP A ANTIGEN DETECTION TEST (MODIFICATION)K952319CONTRAST & RAPID HCG URINE/SERUM TSTK932482MEDIX BIOTECH BESTEST STREP A CAT. NO. BSF1010K932758MEDIX BIOTECH BESTEST HCG-URINE TEST KITK925436MEDIX BIOTECH TOTAL T3 ENZYME IMMUNOASSAY TEST KITK924259MEDIX BIOTECH BESTEST(TM) HCG-URINE, CAT# B1H0100

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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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