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FDA 510(k)

PANTEX DIRECT DHEA-S COATED TUBE RADIOIMMUNOASSAY

K-Number: K853867 · 1985-10-04

ApplicantPantex, Div. Bio-Analysis, Inc.
Decision Date1985-10-04
Product CodeJKC
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

PANTEX DIRECT DHEA-S COATED TUBE RADIOIMMUNOASSAY 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 1985-10-04 under 510(k) number K853867. The device is classified under product code JKC. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PANTEX DIRECT DHEA-S COATED TUBE RADIOIMMUNOASSAY?

PANTEX DIRECT DHEA-S COATED TUBE RADIOIMMUNOASSAY is a medical device that received FDA 510(k) clearance on 1985-10-04. The listed applicant is Pantex, Div. Bio-Analysis, Inc.. The 510(k) number is K853867.

When did PANTEX DIRECT DHEA-S COATED TUBE RADIOIMMUNOASSAY receive FDA 510(k) clearance?

PANTEX DIRECT DHEA-S COATED TUBE RADIOIMMUNOASSAY received FDA 510(k) clearance on 1985-10-04, under 510(k) number K853867.

Who is the listed applicant for PANTEX DIRECT DHEA-S COATED TUBE RADIOIMMUNOASSAY?

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 DHEA-S COATED TUBE RADIOIMMUNOASSAY?

The FDA product code for PANTEX DIRECT DHEA-S COATED TUBE RADIOIMMUNOASSAY is JKC.

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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: JKC)

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.

K040181ACCESS DHEA-S REAGENT ASSAYBeckman Coulter, Inc.K003174ELECSYS DHEA-SRoche Diagnostics Corp.K973897DHEA-SKmi Diagnostics, Inc.K962895DSL DHEA-S-7Diagnostic Systems Laboratories, Inc.K955114DSL AACTIVE DHEA EIA KITDiagnostic Systems Laboratories, Inc.K950524NICHOLS INSTITUTE DIAGNOSTICS DHEA-S CHEMILUMINESCENCE IMMUNOASSAYNichols Institute

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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