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)

TOTAL CALCIUM REAGENT SET

K-Number: K843895 · 1984-10-30

ApplicantLivonia Diagnostics, Inc.
Decision Date1984-10-30
Product CodeCIC
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

TOTAL CALCIUM REAGENT SET is the device name listed in this FDA 510(k) record. The listed applicant is Livonia Diagnostics, Inc.. It received FDA 510(k) clearance on 1984-10-30 under 510(k) number K843895. The device is classified under product code CIC. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TOTAL CALCIUM REAGENT SET?

TOTAL CALCIUM REAGENT SET is a medical device that received FDA 510(k) clearance on 1984-10-30. The listed applicant is Livonia Diagnostics, Inc.. The 510(k) number is K843895.

When did TOTAL CALCIUM REAGENT SET receive FDA 510(k) clearance?

TOTAL CALCIUM REAGENT SET received FDA 510(k) clearance on 1984-10-30, under 510(k) number K843895.

Who is the listed applicant for TOTAL CALCIUM REAGENT SET?

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

What is the FDA product code for TOTAL CALCIUM REAGENT SET?

The FDA product code for TOTAL CALCIUM REAGENT SET is CIC.

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 Livonia Diagnostics, 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.

K852161SERUM IRON/VIBC REAGENT SETK844322SGOT REAGENT SETK844283SGPT REAGENT SETK844237ALKALINE PHOSPHATASE REAGENT SETK844156UREA NITROGEN REAGENT SETK844182INORGANIC PHOSPHORUS REAGENT SET

View all 16 devices →

Related Devices (Code: CIC)

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.

K130870HITACHI CLINICAL ANALYZER S TEST REAGENT CARTRIDGE CALCIUM (CA)Hitachi Chemical Diagnostics, Inc.K083339DIMENSION RXL MAX WITH ADVIA MODULAR AUTOMATION SYSTEM (AMAS)Siemens Healthcare Diagnostics, Inc.K070249ABX PENTRA 400, CALCIUM CP, CREATININE CP, PHOSPHORUS CP, AMYLASE CP, URINE CONTROL L/HHoriba AbxK053401SPOTCHEM II CHEMISTRY BASIC 1 AND CHEMISTRY BASIC 2 TESTSArkray, Inc.K050077SPOTCHEM II CALCIUM, MAGNESIUM, AND BLOOD UREA NITROGEN TESTSArkray, Inc.K041009RAICHEM CALCIUM (OCPC) LIQUID REAGENTHemagen Diagnostics, 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.

↑