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FDA 510(k)

PANTEX DIRECT ESTRADIOL COATED TUBE RADIOIMMUNOASS

K-Number: K853866 · 1985-10-15

ApplicantPantex, Div. Bio-Analysis, Inc.
Decision Date1985-10-15
Product CodeCHP
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

PANTEX DIRECT ESTRADIOL COATED TUBE RADIOIMMUNOASS is the device name listed in this FDA 510(k) record. The listed applicant is Pantex, Div. Bio-Analysis, Inc.. It received FDA 510(k) clearance on 1985-10-15 under 510(k) number K853866. 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 PANTEX DIRECT ESTRADIOL COATED TUBE RADIOIMMUNOASS?

PANTEX DIRECT ESTRADIOL COATED TUBE RADIOIMMUNOASS is a medical device that received FDA 510(k) clearance on 1985-10-15. The listed applicant is Pantex, Div. Bio-Analysis, Inc.. The 510(k) number is K853866.

When did PANTEX DIRECT ESTRADIOL COATED TUBE RADIOIMMUNOASS receive FDA 510(k) clearance?

PANTEX DIRECT ESTRADIOL COATED TUBE RADIOIMMUNOASS received FDA 510(k) clearance on 1985-10-15, under 510(k) number K853866.

Who is the listed applicant for PANTEX DIRECT ESTRADIOL COATED TUBE RADIOIMMUNOASS?

The FDA 510(k) record lists Pantex, Div. Bio-Analysis, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PANTEX DIRECT ESTRADIOL COATED TUBE RADIOIMMUNOASS?

The FDA product code for PANTEX DIRECT ESTRADIOL COATED TUBE RADIOIMMUNOASS is CHP.

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Other records listing Pantex, Div. Bio-Analysis, Inc. 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.

K102841PANTEX AM/PM SALIVARY CORTISOL ENZYME IMMUNOASSAYK942658NEOSCREEN ELISA TSHK914107PROLACTIN IRMA IMMUNOMAGK912804FSH IRMA IMMUNOMAGK911839NEONATAL BLOOD SPOT TEST 17-HYDROXPROG RADIO KITK911050LH IRMA IMMUNOMAG

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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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