Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

TBG DIAGNOSTIC KIT

K-Number: K820252 · 1982-05-05

ApplicantDiagnostic Reagents, Inc.
Decision Date1982-05-05
Product CodeCEE
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

TBG DIAGNOSTIC KIT is the device name listed in this FDA 510(k) record. The listed applicant is Diagnostic Reagents, Inc.. It received FDA 510(k) clearance on 1982-05-05 under 510(k) number K820252. 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 TBG DIAGNOSTIC KIT?

TBG DIAGNOSTIC KIT is a medical device that received FDA 510(k) clearance on 1982-05-05. The listed applicant is Diagnostic Reagents, Inc.. The 510(k) number is K820252.

When did TBG DIAGNOSTIC KIT receive FDA 510(k) clearance?

TBG DIAGNOSTIC KIT received FDA 510(k) clearance on 1982-05-05, under 510(k) number K820252.

Who is the listed applicant for TBG DIAGNOSTIC KIT?

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

What is the FDA product code for TBG DIAGNOSTIC KIT?

The FDA product code for TBG DIAGNOSTIC KIT is CEE.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Diagnostic Reagents, 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.

K983268MODIFICATION OF TRICYCLIC SERUM TOX EIA ASSAYK983812NAPA EIA ASSAYK983323DIGOXIN IMMUNOASSAYK983280VANCOMYCIN EIA ASSAYK983159DRUGS OF ABUSE URINE CALIBRATORS AND CONTROLSK973102LIDOCAINE EIA ASSAY

View all 66 devices →

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.

↑