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)

TMB CHROMOGEN/SUBSTRATE REAGENT SET

K-Number: K920918 · 1992-04-07

ApplicantBio Clinic Co.
Decision Date1992-04-07
Product CodeJHI
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

TMB CHROMOGEN/SUBSTRATE REAGENT SET is the device name listed in this FDA 510(k) record. The listed applicant is Bio Clinic Co.. It received FDA 510(k) clearance on 1992-04-07 under 510(k) number K920918. The device is classified under product code JHI. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TMB CHROMOGEN/SUBSTRATE REAGENT SET?

TMB CHROMOGEN/SUBSTRATE REAGENT SET is a medical device that received FDA 510(k) clearance on 1992-04-07. The listed applicant is Bio Clinic Co.. The 510(k) number is K920918.

When did TMB CHROMOGEN/SUBSTRATE REAGENT SET receive FDA 510(k) clearance?

TMB CHROMOGEN/SUBSTRATE REAGENT SET received FDA 510(k) clearance on 1992-04-07, under 510(k) number K920918.

Who is the listed applicant for TMB CHROMOGEN/SUBSTRATE REAGENT SET?

The FDA 510(k) record lists Bio Clinic Co. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TMB CHROMOGEN/SUBSTRATE REAGENT SET?

The FDA product code for TMB CHROMOGEN/SUBSTRATE REAGENT SET is JHI.

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 Bio Clinic Co. 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.

K930791AMERICAN POWER CONVERSIONS, BACK-UPS 600K932480PRISMK926189ORTHODERM CONSUMMATE AIR THERAPY BED W/SCALEK921958ELISA TUBE TSH TESTK922140ORTHODERM CONVERTIBLE IIK921212MIRCO ELISA HPL TEST KIT

View all 14 devices →

Related Devices (Code: JHI)

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.

K262299Instant-View® hCG Combo II Cassette TestAlfa Scientific Designs, Inc.K241919Innovita HCG Pregnancy Rapid Combo TestInnovita (Tangshan) Biological Technology Co., Ltd.K203272Alltest Pregnancy Rapid Combo Test CassetteHangzhou AllTest Biotech Co., Ltd.K172322Atellica IM Total hCG (ThCG)Siemens Healthcare Diagnostics, Inc.K172257TrueDX hCG Early Result Pregnancy Test (Midstream Format), TrueDX hCG Early Result Pregnancy Test (Cassette Format), VeriClear Early Result Pregnancy Test (Midstream Format), VeriClear Early Result Pregnancy Test (Cassette Format)True Diagnostics, Inc.K152768Assure Tech hCG Pregnancy Serum/Urine Combo Test Cassette, Assure Tech hCG Pregnancy Serum/Urine Combo Test StripAssure Tech. Co., Ltd.

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.

↑