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FDA 510(k)

IMMULITE TOTAL TESTOSTERONE

K-Number: K955870 · 1996-02-06

ApplicantDiagnostic Products Corp.
Decision Date1996-02-06
Product CodeCDZ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

IMMULITE TOTAL 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 1996-02-06 under 510(k) number K955870. 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 IMMULITE TOTAL TESTOSTERONE?

IMMULITE TOTAL TESTOSTERONE is a medical device that received FDA 510(k) clearance on 1996-02-06. The listed applicant is Diagnostic Products Corp.. The 510(k) number is K955870.

When did IMMULITE TOTAL TESTOSTERONE receive FDA 510(k) clearance?

IMMULITE TOTAL TESTOSTERONE received FDA 510(k) clearance on 1996-02-06, under 510(k) number K955870.

Who is the listed applicant for IMMULITE TOTAL 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 IMMULITE TOTAL TESTOSTERONE?

The FDA product code for IMMULITE TOTAL 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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