FDA 510(k)

BIOCIRCUITS IOS SERUM PREGNANCY TEST CARTRIDGES/IMMUNOASSAY CONTROLS

K-Number: K961792 · 1996-08-21

Decision Date1996-08-21

Product CodeDHA

Advisory CommitteeCH

DecisionSubstantially Equivalent

Device Summary

BIOCIRCUITS IOS SERUM PREGNANCY TEST CARTRIDGES/IMMUNOASSAY CONTROLS is the device name listed in this FDA 510(k) record. The listed applicant is Biocircuits Corp.. It received FDA 510(k) clearance on 1996-08-21 under 510(k) number K961792. The device is classified under product code DHA. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BIOCIRCUITS IOS SERUM PREGNANCY TEST CARTRIDGES/IMMUNOASSAY CONTROLS?

BIOCIRCUITS IOS SERUM PREGNANCY TEST CARTRIDGES/IMMUNOASSAY CONTROLS is a medical device that received FDA 510(k) clearance on 1996-08-21. The listed applicant is Biocircuits Corp.. The 510(k) number is K961792.

When did BIOCIRCUITS IOS SERUM PREGNANCY TEST CARTRIDGES/IMMUNOASSAY CONTROLS receive FDA 510(k) clearance?

BIOCIRCUITS IOS SERUM PREGNANCY TEST CARTRIDGES/IMMUNOASSAY CONTROLS received FDA 510(k) clearance on 1996-08-21, under 510(k) number K961792.

Who is the listed applicant for BIOCIRCUITS IOS SERUM PREGNANCY TEST CARTRIDGES/IMMUNOASSAY CONTROLS?

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

What is the FDA product code for BIOCIRCUITS IOS SERUM PREGNANCY TEST CARTRIDGES/IMMUNOASSAY CONTROLS?

The FDA product code for BIOCIRCUITS IOS SERUM PREGNANCY TEST CARTRIDGES/IMMUNOASSAY CONTROLS is DHA.

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_RECRUITING NCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITING NCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED NCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Biocircuits Corp. as applicant

K981634BIOCIRCUITS IOS PROSTATE SPECIFIC ANTIGEN (PSA) TEST CARTRIDGES, BIOCIRCUITS IOS PSA CONTROLS K980819BIOCIRCUITS IOS FREE THYROXINE (FT4) TEST CARTRIDGES BIOCIRCUITS IOS CONTROLS K963770BIOCIRCUITS IOS QUANTITATIVE HCG TEST CARTRIDGES/BIOCIRCUITS IOS IMMUNOASSAY CONTROLS K961566BIOCIRCUITS IOS TSH TEST CARTRIDGES/THYROID CONTROLS K952719BIOCIRCUITS IOS (IN-OFFICE SYSTEM)K952751BIOCIRCUITS IOS T4/TU TEST CARTRIDGES

View all 8 devices →

Related Devices (Code: DHA)

K233581VITROS Immunodiagnostic Products Total ß-hCG II Reagent PackOrtho Clinical Diagnostics K223690iFlash-HCG; Chemiluminescence Immunoassay Analyzer (Model: iFlash 3000-C)Shenzhen Yhlo Biotech Co., Ltd.K230937Alinity i Total ß-hCG Reagent Kit, GLP systems TrackAbbott Laboratories K230790Alinity i Total B-hCG Reagent Kit, Alinity c Glucose Reagent Kit, Alinity c ICT Sample Diluent, Alinity ci-seriesAbbott Laboratories K221990Access Total ßhCG (5th IS)Beckman Coulter, Inc.K212221Diazyme DZ-Lite iFlash Total beta-hCG Assay, Diazyme DZ-Lite iFlash 1800 Chemiluminescence Immunoassay AnalyzerDiazyme 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.