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FDA 510(k)

TIPSEP-CORTISOL RIA DIAGNOSTIC KIT

K-Number: K872177 · 1987-06-17

ApplicantNuclear Diagnostics, Inc.
Decision Date1987-06-17
Product CodeCGR
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

TIPSEP-CORTISOL RIA DIAGNOSTIC KIT is the device name listed in this FDA 510(k) record. The listed applicant is Nuclear Diagnostics, Inc.. It received FDA 510(k) clearance on 1987-06-17 under 510(k) number K872177. 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 TIPSEP-CORTISOL RIA DIAGNOSTIC KIT?

TIPSEP-CORTISOL RIA DIAGNOSTIC KIT is a medical device that received FDA 510(k) clearance on 1987-06-17. The listed applicant is Nuclear Diagnostics, Inc.. The 510(k) number is K872177.

When did TIPSEP-CORTISOL RIA DIAGNOSTIC KIT receive FDA 510(k) clearance?

TIPSEP-CORTISOL RIA DIAGNOSTIC KIT received FDA 510(k) clearance on 1987-06-17, under 510(k) number K872177.

Who is the listed applicant for TIPSEP-CORTISOL RIA DIAGNOSTIC KIT?

The FDA 510(k) record lists Nuclear Diagnostics, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TIPSEP-CORTISOL RIA DIAGNOSTIC KIT?

The FDA product code for TIPSEP-CORTISOL RIA DIAGNOSTIC KIT is CGR.

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Other records listing Nuclear Diagnostics, 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.

K923917ELIPASE HUMAN PANCREATIC LIPASE ENZYMEIMMUNOASSAYK932406NUCLITRYP(TM)(I125)-HUMAN PANCREA CATH TRY RAD KITK862312ENZLIPASE, ENZYMATIC LIPASE KITK860472NUCLEAR LASER ALIGNMENT SYSTEM FOR CARDIC STRESSK861735TIPSEP-TBG ASSAYK852291TIPSEP DIGOXIN RIA

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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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