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FDA 510(k)

PANTEX DIRECT TESTOSTERONE COATED TUBE RADIOIMMUNO

K-Number: K853865 · 1985-10-15

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

Device Summary

PANTEX DIRECT TESTOSTERONE COATED TUBE RADIOIMMUNO 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 K853865. 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 PANTEX DIRECT TESTOSTERONE COATED TUBE RADIOIMMUNO?

PANTEX DIRECT TESTOSTERONE COATED TUBE RADIOIMMUNO 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 K853865.

When did PANTEX DIRECT TESTOSTERONE COATED TUBE RADIOIMMUNO receive FDA 510(k) clearance?

PANTEX DIRECT TESTOSTERONE COATED TUBE RADIOIMMUNO received FDA 510(k) clearance on 1985-10-15, under 510(k) number K853865.

Who is the listed applicant for PANTEX DIRECT TESTOSTERONE COATED TUBE RADIOIMMUNO?

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 TESTOSTERONE COATED TUBE RADIOIMMUNO?

The FDA product code for PANTEX DIRECT TESTOSTERONE COATED TUBE RADIOIMMUNO is CDZ.

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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: CDZ)

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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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