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FDA 510(k)

PROSTATE SPECIFIC ANTIGEN (RSA) CONTROL MODDULE (PSACM)

K-Number: K962975 · 1996-08-29

ApplicantDiagnostic Products Corp.
Decision Date1996-08-29
Product CodeJJX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

PROSTATE SPECIFIC ANTIGEN (RSA) CONTROL MODDULE (PSACM) 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 1996-08-29 under 510(k) number K962975. The device is classified under product code JJX. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PROSTATE SPECIFIC ANTIGEN (RSA) CONTROL MODDULE (PSACM)?

PROSTATE SPECIFIC ANTIGEN (RSA) CONTROL MODDULE (PSACM) is a medical device that received FDA 510(k) clearance on 1996-08-29. The listed applicant is Diagnostic Products Corp.. The 510(k) number is K962975.

When did PROSTATE SPECIFIC ANTIGEN (RSA) CONTROL MODDULE (PSACM) receive FDA 510(k) clearance?

PROSTATE SPECIFIC ANTIGEN (RSA) CONTROL MODDULE (PSACM) received FDA 510(k) clearance on 1996-08-29, under 510(k) number K962975.

Who is the listed applicant for PROSTATE SPECIFIC ANTIGEN (RSA) CONTROL MODDULE (PSACM)?

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 PROSTATE SPECIFIC ANTIGEN (RSA) CONTROL MODDULE (PSACM)?

The FDA product code for PROSTATE SPECIFIC ANTIGEN (RSA) CONTROL MODDULE (PSACM) is JJX.

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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: JJX)

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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