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FDA 510(k)

COAT-A-COUNT DIRECT ANDROSTENEDIONE

K-Number: K954755 · 1995-11-29

ApplicantDiagnostic Products Corp.
Decision Date1995-11-29
Product CodeCIZ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

COAT-A-COUNT DIRECT ANDROSTENEDIONE 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 1995-11-29 under 510(k) number K954755. The device is classified under product code CIZ. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the COAT-A-COUNT DIRECT ANDROSTENEDIONE?

COAT-A-COUNT DIRECT ANDROSTENEDIONE is a medical device that received FDA 510(k) clearance on 1995-11-29. The listed applicant is Diagnostic Products Corp.. The 510(k) number is K954755.

When did COAT-A-COUNT DIRECT ANDROSTENEDIONE receive FDA 510(k) clearance?

COAT-A-COUNT DIRECT ANDROSTENEDIONE received FDA 510(k) clearance on 1995-11-29, under 510(k) number K954755.

Who is the listed applicant for COAT-A-COUNT DIRECT ANDROSTENEDIONE?

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 COAT-A-COUNT DIRECT ANDROSTENEDIONE?

The FDA product code for COAT-A-COUNT DIRECT ANDROSTENEDIONE is CIZ.

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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.

K063045IMMULITE 2000, IMMULITE 2500 VANCOMYCINK034055IMMULITE 2500 CK-MB, 2500 MYOGLOBIN, 2500 STAT TROPONIN IK033234IMMULITE 2500 AUTOMATED IMMUNOASSAY ANALYZERK032881IMMULITE/IMMULITE 1000 TOTAL TESTOSTERONE AND IMMULITE 2000 TOTAL TESTOSTERONEK023152IMMULITE 2000 ALLERGEN-SPECIFIC IGEK023304IMMULITE/IMMULITE 1000 CALCITONIN, MODEL LKCL AND IMMULITE 2000 CALCITONIN, MODEL L2KCL

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Related Devices (Code: CIZ)

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.

K963002ACTIVE ANDROSTENEDIONE EIADiagnostic Systems Laboratories, Inc.K934751ACTIVE ANDROSTANEDIOL GLUCURONIDEDiagnostic Systems Laboratories, Inc.K860559ANDROSTENEDIONE 125I KIT BY RIAImmuchem Corp.K854673DSL ANDROSTENEDIONE RIA (DSL # 4200)Diagnostic Systems Laboratories, Inc.K854650DSL ACTIVE ANDROSTENEDIONE RIA (DSL #3800)Diagnostic Systems Laboratories, Inc.K844398COAT-A-COUNT ANDROSTENEDIONE RIA KITDiagnostic Products Corp.

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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