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)

BCG REAGENT SERUM ALBUMIN W/TECHNICON

K-Number: K802157 · 1980-10-10

ApplicantPanmed, Inc.
Decision Date1980-10-10
Product CodeCIX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

BCG REAGENT SERUM ALBUMIN W/TECHNICON is the device name listed in this FDA 510(k) record. The listed applicant is Panmed, Inc.. It received FDA 510(k) clearance on 1980-10-10 under 510(k) number K802157. The device is classified under product code CIX. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BCG REAGENT SERUM ALBUMIN W/TECHNICON?

BCG REAGENT SERUM ALBUMIN W/TECHNICON is a medical device that received FDA 510(k) clearance on 1980-10-10. The listed applicant is Panmed, Inc.. The 510(k) number is K802157.

When did BCG REAGENT SERUM ALBUMIN W/TECHNICON receive FDA 510(k) clearance?

BCG REAGENT SERUM ALBUMIN W/TECHNICON received FDA 510(k) clearance on 1980-10-10, under 510(k) number K802157.

Who is the listed applicant for BCG REAGENT SERUM ALBUMIN W/TECHNICON?

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

What is the FDA product code for BCG REAGENT SERUM ALBUMIN W/TECHNICON?

The FDA product code for BCG REAGENT SERUM ALBUMIN W/TECHNICON is CIX.

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 Panmed, 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.

K852767ERYTHOCYTE CREATINEK820642SICKLE-CHECKK8021648-HYDROXYQUINOLINE, CRESOLPHTHALEIN COM.K802163CHLORIDE COLOR & CHLORIDE SAMPLE DILUENTK802159AMMONIUM MOLYBDATE INORGANIC PHOSPHORUSK802155REAGENTS SERUM SODIUM USING THE TECH.

View all 16 devices →

Related Devices (Code: CIX)

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.

K251157Core MetabolicTruvian HealthK203248Albumin BCG2Abbott Ireland Diagnostics DivisionK200898Medicon Hellas Albumin, Medicon Hellas Calcium, Medicon Hellas Creatinine, Medicon Hellas Urea Nitrogen, Medicon Hellas Glucose, Medicon Hellas Total Bilirubin, Medicon Hellas Direct BilirubinMedicon Hellas S.AK191316VITROS XT Chemistry Products ALB-TP SlidesOrtho-Clinical Diagnostics, Inc.K170901ALBUMIN, ALKALINE PHOSPHATASE (ALP)-AMP, GLUCOSE-HEXOKINASE, BA400Biosystems S.A.K131488ACE ALBUMIN REAGENT, ACE TOTAL PROTEIN REAGENT, ACE CALCIUM-ARSENAZO REAGENT AND ACE PHOSPHORUS REAGENTAlfa Wassermann Diagnostics Technologies, LLC

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.

↑