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FDA 510(k)

FSH IRMA IMMUNOMAG

K-Number: K912804 · 1991-08-12

ApplicantPantex, Div. Bio-Analysis, Inc.
Decision Date1991-08-12
Product CodeCGJ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

FSH IRMA IMMUNOMAG is the device name listed in this FDA 510(k) record. The listed applicant is Pantex, Div. Bio-Analysis, Inc.. It received FDA 510(k) clearance on 1991-08-12 under 510(k) number K912804. 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 IRMA IMMUNOMAG?

FSH IRMA IMMUNOMAG is a medical device that received FDA 510(k) clearance on 1991-08-12. The listed applicant is Pantex, Div. Bio-Analysis, Inc.. The 510(k) number is K912804.

When did FSH IRMA IMMUNOMAG receive FDA 510(k) clearance?

FSH IRMA IMMUNOMAG received FDA 510(k) clearance on 1991-08-12, under 510(k) number K912804.

Who is the listed applicant for FSH IRMA IMMUNOMAG?

The FDA 510(k) record lists Pantex, Div. Bio-Analysis, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for FSH IRMA IMMUNOMAG?

The FDA product code for FSH IRMA IMMUNOMAG is CGJ.

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Other records listing Pantex, Div. Bio-Analysis, 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.

K102841PANTEX AM/PM SALIVARY CORTISOL ENZYME IMMUNOASSAYK942658NEOSCREEN ELISA TSHK914107PROLACTIN IRMA IMMUNOMAGK911839NEONATAL BLOOD SPOT TEST 17-HYDROXPROG RADIO KITK911050LH IRMA IMMUNOMAGK910717PANTEX IRMA LH 1251 KIT

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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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