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FDA 510(k)

COAT-A-COUNT NO-EXTRACTION TESTOSTERONE

K-Number: K831342 · 1983-06-02

ApplicantDiagnostic Products Corp.
Decision Date1983-06-02
Product CodeCDZ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

COAT-A-COUNT NO-EXTRACTION TESTOSTERONE 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 1983-06-02 under 510(k) number K831342. 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 COAT-A-COUNT NO-EXTRACTION TESTOSTERONE?

COAT-A-COUNT NO-EXTRACTION TESTOSTERONE is a medical device that received FDA 510(k) clearance on 1983-06-02. The listed applicant is Diagnostic Products Corp.. The 510(k) number is K831342.

When did COAT-A-COUNT NO-EXTRACTION TESTOSTERONE receive FDA 510(k) clearance?

COAT-A-COUNT NO-EXTRACTION TESTOSTERONE received FDA 510(k) clearance on 1983-06-02, under 510(k) number K831342.

Who is the listed applicant for COAT-A-COUNT NO-EXTRACTION TESTOSTERONE?

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 NO-EXTRACTION TESTOSTERONE?

The FDA product code for COAT-A-COUNT NO-EXTRACTION TESTOSTERONE 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.

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: 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.

K252728IDS-iSYS Total TestosteroneImmunodiagnostic Systems LimitedK240865IDS-iSYS Free TestosteroneImmunodiagnostic Systems LimitedK233480Access SHBGBeckman Coulter, Inc.K223405Access TestosteroneBeckman Coulter, Inc.K211685Elecsys Testosterone IIRoche DiagnosticsK201908LIAISON Testosterone xtDiaSorin, Inc.

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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