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FDA 510(k)

SPINSEP-TBG

K-Number: K771341 · 1977-08-10

ApplicantNuclear Diagnostics, Inc.
Decision Date1977-08-10
Product CodeCEE
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

SPINSEP-TBG 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 1977-08-10 under 510(k) number K771341. 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 SPINSEP-TBG?

SPINSEP-TBG is a medical device that received FDA 510(k) clearance on 1977-08-10. The listed applicant is Nuclear Diagnostics, Inc.. The 510(k) number is K771341.

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

SPINSEP-TBG received FDA 510(k) clearance on 1977-08-10, under 510(k) number K771341.

Who is the listed applicant for SPINSEP-TBG?

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 SPINSEP-TBG?

The FDA product code for SPINSEP-TBG 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 STRESSK861735TIPSEP-TBG ASSAY

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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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