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FDA 510(k)

IRMA-COUNT (TM) SHBG (SEX HORMORNE BIND GLOBULIN)

K-Number: K883267 · 1988-10-31

ApplicantDiagnostic Products Corp.
Decision Date1988-10-31
Product CodeCDZ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

IRMA-COUNT (TM) SHBG (SEX HORMORNE BIND GLOBULIN) is the device name listed in this FDA 510(k) record. The listed applicant is Diagnostic Products Corp.. It received FDA 510(k) clearance on 1988-10-31 under 510(k) number K883267. The device is classified under product code CDZ. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IRMA-COUNT (TM) SHBG (SEX HORMORNE BIND GLOBULIN)?

IRMA-COUNT (TM) SHBG (SEX HORMORNE BIND GLOBULIN) is a medical device that received FDA 510(k) clearance on 1988-10-31. The listed applicant is Diagnostic Products Corp.. The 510(k) number is K883267.

When did IRMA-COUNT (TM) SHBG (SEX HORMORNE BIND GLOBULIN) receive FDA 510(k) clearance?

IRMA-COUNT (TM) SHBG (SEX HORMORNE BIND GLOBULIN) received FDA 510(k) clearance on 1988-10-31, under 510(k) number K883267.

Who is the listed applicant for IRMA-COUNT (TM) SHBG (SEX HORMORNE BIND GLOBULIN)?

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

What is the FDA product code for IRMA-COUNT (TM) SHBG (SEX HORMORNE BIND GLOBULIN)?

The FDA product code for IRMA-COUNT (TM) SHBG (SEX HORMORNE BIND GLOBULIN) is CDZ.

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Other records listing Diagnostic Products 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.

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Related Devices (Code: CDZ)

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.

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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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