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FDA 510(k)

TIPSEP-TBG ASSAY

K-Number: K861735 · 1986-06-13

ApplicantNuclear Diagnostics, Inc.
Decision Date1986-06-13
Product CodeCEE
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

TIPSEP-TBG ASSAY 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 1986-06-13 under 510(k) number K861735. The device is classified under product code CEE. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TIPSEP-TBG ASSAY?

TIPSEP-TBG ASSAY is a medical device that received FDA 510(k) clearance on 1986-06-13. The listed applicant is Nuclear Diagnostics, Inc.. The 510(k) number is K861735.

When did TIPSEP-TBG ASSAY receive FDA 510(k) clearance?

TIPSEP-TBG ASSAY received FDA 510(k) clearance on 1986-06-13, under 510(k) number K861735.

Who is the listed applicant for TIPSEP-TBG ASSAY?

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-TBG ASSAY?

The FDA product code for TIPSEP-TBG ASSAY is CEE.

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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 KITK872177TIPSEP-CORTISOL RIA DIAGNOSTIC KITK862312ENZLIPASE, ENZYMATIC LIPASE KITK860472NUCLEAR LASER ALIGNMENT SYSTEM FOR CARDIC STRESSK852291TIPSEP DIGOXIN RIA

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Related Devices (Code: CEE)

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.

K952284AMERLITE TBG ASSAYJohnson & Johnson Clinical Diagnostics, Inc.K930010ACCESS THYROID UPTAKE ASSAYBio-Rad Laboratories, Inc.K910677IMMULITE(TM) T-UPTAKECirrus Diagnostics, Inc.K905777MICROZYME THYROID UPTAKE ENZYME IMMUNOASSAY KITImmunotech Corp.K900240DELFIA TBG KITPharmacia, Inc.K896991ENZYMUN TEST(R) TBKBoehringer Mannheim Corp.

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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