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FDA 510(k)

IRMA-COUNT LH W/MONO. ANTIBODIES RKLH1,2,5

K-Number: K874032 · 1987-12-30

ApplicantDiagnostic Products Corp.
Decision Date1987-12-30
Product CodeCEP
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

IRMA-COUNT LH W/MONO. ANTIBODIES RKLH1,2,5 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 1987-12-30 under 510(k) number K874032. The device is classified under product code CEP. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IRMA-COUNT LH W/MONO. ANTIBODIES RKLH1,2,5?

IRMA-COUNT LH W/MONO. ANTIBODIES RKLH1,2,5 is a medical device that received FDA 510(k) clearance on 1987-12-30. The listed applicant is Diagnostic Products Corp.. The 510(k) number is K874032.

When did IRMA-COUNT LH W/MONO. ANTIBODIES RKLH1,2,5 receive FDA 510(k) clearance?

IRMA-COUNT LH W/MONO. ANTIBODIES RKLH1,2,5 received FDA 510(k) clearance on 1987-12-30, under 510(k) number K874032.

Who is the listed applicant for IRMA-COUNT LH W/MONO. ANTIBODIES RKLH1,2,5?

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 LH W/MONO. ANTIBODIES RKLH1,2,5?

The FDA product code for IRMA-COUNT LH W/MONO. ANTIBODIES RKLH1,2,5 is CEP.

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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: CEP)

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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