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*SR (TOTAL) LIQUID STABLE REAGENT SET

K-Number: K861413 · 1986-04-24

ApplicantMedical Analysis Systems, Inc.
Decision Date1986-04-24
Product CodeCIG
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

BILIRUBIN*SR (TOTAL) LIQUID STABLE REAGENT SET is the device name listed in this FDA 510(k) record. The listed applicant is Medical Analysis Systems, Inc.. It received FDA 510(k) clearance on 1986-04-24 under 510(k) number K861413. 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*SR (TOTAL) LIQUID STABLE REAGENT SET?

BILIRUBIN*SR (TOTAL) LIQUID STABLE REAGENT SET is a medical device that received FDA 510(k) clearance on 1986-04-24. The listed applicant is Medical Analysis Systems, Inc.. The 510(k) number is K861413.

When did BILIRUBIN*SR (TOTAL) LIQUID STABLE REAGENT SET receive FDA 510(k) clearance?

BILIRUBIN*SR (TOTAL) LIQUID STABLE REAGENT SET received FDA 510(k) clearance on 1986-04-24, under 510(k) number K861413.

Who is the listed applicant for BILIRUBIN*SR (TOTAL) LIQUID STABLE REAGENT SET?

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

What is the FDA product code for BILIRUBIN*SR (TOTAL) LIQUID STABLE REAGENT SET?

The FDA product code for BILIRUBIN*SR (TOTAL) LIQUID STABLE REAGENT SET 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 Medical Analysis Systems, 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.

K042717MAS, DADE AND LIQUID ASSAYED DIABETES CONTROLK041194ABBOTT ARCHITECT STAT TROPONIN I LIQUID ASSAYED CARDIAC MARKER CONTROL LEVEL L, M AND HK040880MAS CARDIOIMMUNE TL LIQUID ASSAYED CARDIAC MARKER CONTROL, LEVELS 1,2 AND 3K032826MAS PAR TDMK032335MAS CARDIOIMMUNE PROBNP, MAS CARDIOIMMUNE TLK031890MAS BILIRUBIN LIQUID ASSAYED BILIRUBIN CONTROL

View all 107 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.

↑