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FDA 510(k)

PANCOAT CORTISOL COATED TUBE RADIOIMMUNOASSAY KIT

K-Number: K862336 · 1986-09-25

ApplicantPantex, Div. Bio-Analysis, Inc.
Decision Date1986-09-25
Product CodeCGR
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

PANCOAT CORTISOL COATED TUBE RADIOIMMUNOASSAY KIT 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 1986-09-25 under 510(k) number K862336. The device is classified under product code CGR. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PANCOAT CORTISOL COATED TUBE RADIOIMMUNOASSAY KIT?

PANCOAT CORTISOL COATED TUBE RADIOIMMUNOASSAY KIT is a medical device that received FDA 510(k) clearance on 1986-09-25. The listed applicant is Pantex, Div. Bio-Analysis, Inc.. The 510(k) number is K862336.

When did PANCOAT CORTISOL COATED TUBE RADIOIMMUNOASSAY KIT receive FDA 510(k) clearance?

PANCOAT CORTISOL COATED TUBE RADIOIMMUNOASSAY KIT received FDA 510(k) clearance on 1986-09-25, under 510(k) number K862336.

Who is the listed applicant for PANCOAT CORTISOL COATED TUBE RADIOIMMUNOASSAY KIT?

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 PANCOAT CORTISOL COATED TUBE RADIOIMMUNOASSAY KIT?

The FDA product code for PANCOAT CORTISOL COATED TUBE RADIOIMMUNOASSAY KIT is CGR.

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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: CGR)

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.

K242190Access Cortisol; DxC 500i Clinical AnalyzerBeckman Coulter, Inc.K223038Access CortisolBeckman Coulter, Inc.K202136IDS CortisolImmunodiagnostic Systems , Ltd.K202826IMMULITE® 2000 CortisolSiemens Healthcare Diagnostics Products, Ltd.K203270IMMULITE/IMMULITE® 1000 CortisolSiemens Healthcare Diagnostics Products, Ltd.K062626CORTISOL ELISAIbl-Hamburg GmbH

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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