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FDA 510(k)

AI-PHOTODIAGNOSTIC

K-Number: K940004 · 1995-08-04

ApplicantPharmarceutical Discovery Corp.
Decision Date1995-08-04
Product CodeCIB
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

AI-PHOTODIAGNOSTIC is the device name listed in this FDA 510(k) record. The listed applicant is Pharmarceutical Discovery Corp.. It received FDA 510(k) clearance on 1995-08-04 under 510(k) number K940004. The device is classified under product code CIB. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AI-PHOTODIAGNOSTIC?

AI-PHOTODIAGNOSTIC is a medical device that received FDA 510(k) clearance on 1995-08-04. The listed applicant is Pharmarceutical Discovery Corp.. The 510(k) number is K940004.

When did AI-PHOTODIAGNOSTIC receive FDA 510(k) clearance?

AI-PHOTODIAGNOSTIC received FDA 510(k) clearance on 1995-08-04, under 510(k) number K940004.

Who is the listed applicant for AI-PHOTODIAGNOSTIC?

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

What is the FDA product code for AI-PHOTODIAGNOSTIC?

The FDA product code for AI-PHOTODIAGNOSTIC is CIB.

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Related Devices (Code: CIB)

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.

K123763IDS ISYS DIRECT RENIN ASSAY, IDS ISYS DIRECT RENIN CONTROL SET, AND IDS ISYS DIRECT RENIN CALIBRATION VERIFIERSImmunodiagnostic Systems , Ltd.K121944LIAISON DIRECT RENIN LIAISON CONTROL DIRECT RENIN LIAISON ENDOCRINOLOGY DILUENTDiaSorin, Inc.K062120CISBIO RENIN RIA TESTCis Bio InternationalK061758ACTIVE RENIN IRMADiagnostic Systems Laboratories, Inc.K011128NICHOLS ADVANTAGE DIRECT RENIN (CALIBRATORS, CALIBRATION VERIFIERS, CONTROLS, AND SAMPLE DILUENT)Nichols Institute DiagnosticsK981607ACTIVE RENIN IRMA MODEL NUMBER DSL-25100Diagnostic Systems Laboratories, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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