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)

BILIRUBIN RAPID STAT KIT

K-Number: K780826 · 1978-05-26

ApplicantPierce Chemical Co.
Decision Date1978-05-26
Product CodeCIG
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

BILIRUBIN RAPID STAT KIT is the device name listed in this FDA 510(k) record. The listed applicant is Pierce Chemical Co.. It received FDA 510(k) clearance on 1978-05-26 under 510(k) number K780826. The device is classified under product code CIG. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BILIRUBIN RAPID STAT KIT?

BILIRUBIN RAPID STAT KIT is a medical device that received FDA 510(k) clearance on 1978-05-26. The listed applicant is Pierce Chemical Co.. The 510(k) number is K780826.

When did BILIRUBIN RAPID STAT KIT receive FDA 510(k) clearance?

BILIRUBIN RAPID STAT KIT received FDA 510(k) clearance on 1978-05-26, under 510(k) number K780826.

Who is the listed applicant for BILIRUBIN RAPID STAT KIT?

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

What is the FDA product code for BILIRUBIN RAPID STAT KIT?

The FDA product code for BILIRUBIN RAPID STAT KIT is CIG.

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 Pierce Chemical 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.

K895661GLYCOTEST II GLYHB ASSAY KITK831837CLINOVATIVE II DIAGNOSTIC KITK821360GLYCO-GEL TEST KITK820279GLYCO-GEL TEST KITK781897STAT KIT, MICROPROTEINK780827URIC ACID RAPID STAT KIT

View all 10 devices →

Related Devices (Code: CIG)

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.

K251998Atellica CH Diazo Total Bilirubin (D_TBil)Siemens Healthcare Diagnostics, Inc.K223078Atellica® CH Diazo Direct Bilirubin (D_DBil)Siemens Healthcare Diagnostics, Inc.K222104Atellica® CH Diazo Total Bilirubin (D_TBil)Siemens Healthcare Diagnostics, Inc.K223324Total Bilirubin2Abbott Ireland Diagnostics DivisionK190807VITROS XT Chemistry Products TBIL-ALKP SlidesOrtho-Clinical Diagnostics, Inc.K171401ELITech Clinical Systems BILIRUBIN TOTAL 4+1, ELITech Clinical Systems BILIRUBIN DIRECT 4+1Elitechgroup

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.

↑