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FDA 510(k)

COAT-A-COUNT(R) ESTRADIOL-6

K-Number: K943193 · 1995-02-23

ApplicantDiagnostic Products Corp.
Decision Date1995-02-23
Product CodeCHP
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

COAT-A-COUNT(R) ESTRADIOL-6 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 1995-02-23 under 510(k) number K943193. The device is classified under product code CHP. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the COAT-A-COUNT(R) ESTRADIOL-6?

COAT-A-COUNT(R) ESTRADIOL-6 is a medical device that received FDA 510(k) clearance on 1995-02-23. The listed applicant is Diagnostic Products Corp.. The 510(k) number is K943193.

When did COAT-A-COUNT(R) ESTRADIOL-6 receive FDA 510(k) clearance?

COAT-A-COUNT(R) ESTRADIOL-6 received FDA 510(k) clearance on 1995-02-23, under 510(k) number K943193.

Who is the listed applicant for COAT-A-COUNT(R) ESTRADIOL-6?

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(R) ESTRADIOL-6?

The FDA product code for COAT-A-COUNT(R) ESTRADIOL-6 is CHP.

Related Clinical Trials

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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: CHP)

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.

K041349LUMINESCENT IMMUNOASSAY KIT FOR THE DETECTION OF ESTRADIOL IN SALIVA AND SERUMIbl GmbHK97390117 B-ESTRADIOL (ELISA)Kmi Diagnostics, Inc.K973743ACCESS ESTRADIOL REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZERBeckman Instruments, Inc.K970386ACS ESTADIOL-6 IIChiron Diagnostics Corp.K970643VITROS IMMUNODIAGNOSTICS PRODUCTS ESTRADIOL REAGENT PACK(GEM. 1050)/ESTRADIOL CALIBRATORS (GEM.C050)Johnson & Johnson Clinical Diagnostics, Inc.K970126ACCESS ESTRADIOL REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER (33550,33540,33545)Bio-Rad Laboratories, 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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