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)

PROCHECK(TM) BLIND PERFORMANCE SPECIMENS

K-Number: K931105 · 1993-04-21

ApplicantDynagen, Inc.
Decision Date1993-04-21
Product CodeDIF
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

PROCHECK(TM) BLIND PERFORMANCE SPECIMENS is the device name listed in this FDA 510(k) record. The listed applicant is Dynagen, Inc.. It received FDA 510(k) clearance on 1993-04-21 under 510(k) number K931105. The device is classified under product code DIF. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PROCHECK(TM) BLIND PERFORMANCE SPECIMENS?

PROCHECK(TM) BLIND PERFORMANCE SPECIMENS is a medical device that received FDA 510(k) clearance on 1993-04-21. The listed applicant is Dynagen, Inc.. The 510(k) number is K931105.

When did PROCHECK(TM) BLIND PERFORMANCE SPECIMENS receive FDA 510(k) clearance?

PROCHECK(TM) BLIND PERFORMANCE SPECIMENS received FDA 510(k) clearance on 1993-04-21, under 510(k) number K931105.

Who is the listed applicant for PROCHECK(TM) BLIND PERFORMANCE SPECIMENS?

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

What is the FDA product code for PROCHECK(TM) BLIND PERFORMANCE SPECIMENS?

The FDA product code for PROCHECK(TM) BLIND PERFORMANCE SPECIMENS is DIF.

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 Dynagen, 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.

K963733NICCHECK IK943051MYCOAKT M. TUBERCULOSIS CUULTURE ID KITK943050MYCOAKT M KANSASII CULTURE ID KITK943049MYCOAKT M. AVIUM CULTURE ID KITK912888URITEC TEST STRIP & HUMAN URINE + & - TEST CONTROL

Related Devices (Code: DIF)

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.

K153474Detectabuse Liquid Control Urine, Detectabuse Stat-Skreen Liquid Control Urine, Detectabuse Liquid Control Urine, AU/NZ, Detectabuse Liquid Control Urine, Immunoassay Series, Detectabuse Liquid Control Urine, GC/MS and Confirm seriesBiochemical Diagnostics, Inc.K132688SALIVABUSE LIQUID ORAL FLUID CONTROL, SALIVABUSE LIQUID ORAL FLUID CONTROL, AU/NZBiochemical Diagnostics, Inc.K132174MULTICHEM WBTTechno-Path Manufacturing , Ltd.K121122DETECTABUSE LIQUID CONTROL, DETECTABUSE STAT-SKREEN LIQUID CONTROLBiochemical Diagnostic, Inc.K121143LIQUICHEK WHOLE BLOOD IMMUNOSUPPRESSANT CONTROL TILEVEL (1,2 AND 3)Bio-Rad LaboratoriesK120504LIQUICHEK URINE TOXICOLOGY CONTROL, S10 & S10 MINIPAK, LIQUICHEK URINE TOXICOLOGY CONTROL, LEVEL S20 & LEVEL S20 MINIPAKBio-Rad Laboratories, Inc.

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.

↑