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FDA 510(k)

ELECSYS FSH ASSAY

K-Number: K964693 · 1996-12-16

ApplicantBoehringer Mannheim Corp.
Decision Date1996-12-16
Product CodeCGJ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ELECSYS FSH ASSAY is the device name listed in this FDA 510(k) record. The listed applicant is Boehringer Mannheim Corp.. It received FDA 510(k) clearance on 1996-12-16 under 510(k) number K964693. 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 ELECSYS FSH ASSAY?

ELECSYS FSH ASSAY is a medical device that received FDA 510(k) clearance on 1996-12-16. The listed applicant is Boehringer Mannheim Corp.. The 510(k) number is K964693.

When did ELECSYS FSH ASSAY receive FDA 510(k) clearance?

ELECSYS FSH ASSAY received FDA 510(k) clearance on 1996-12-16, under 510(k) number K964693.

Who is the listed applicant for ELECSYS FSH ASSAY?

The FDA 510(k) record lists Boehringer Mannheim Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ELECSYS FSH ASSAY?

The FDA product code for ELECSYS FSH ASSAY is CGJ.

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Other records listing Boehringer Mannheim Corp. 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.

K984326ELECYS IGE ASSAYK983047ACCU-CHEK HQ SYSTEMK984419ELECSYS IGE CALCHECKK984425MODIFICATION OF PRECISET SERUM PROTEINS CALIBRATORK984372ELECSYS CALCHECK TROPONIN TK984105ELECSYS TROPONIN T STAT TEST

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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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