FDA 510(k)

PRISMA C-REACTIVE PROTEIN CONTROLS

K-Number: K823415 · 1982-12-09

Decision Date1982-12-09

Product CodeDCK

Advisory CommitteeIM

DecisionSubstantially Equivalent

Device Summary

PRISMA C-REACTIVE PROTEIN CONTROLS is the device name listed in this FDA 510(k) record. The listed applicant is Syva Co.. It received FDA 510(k) clearance on 1982-12-09 under 510(k) number K823415. The device is classified under product code DCK. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PRISMA C-REACTIVE PROTEIN CONTROLS?

PRISMA C-REACTIVE PROTEIN CONTROLS is a medical device that received FDA 510(k) clearance on 1982-12-09. The listed applicant is Syva Co.. The 510(k) number is K823415.

When did PRISMA C-REACTIVE PROTEIN CONTROLS receive FDA 510(k) clearance?

PRISMA C-REACTIVE PROTEIN CONTROLS received FDA 510(k) clearance on 1982-12-09, under 510(k) number K823415.

Who is the listed applicant for PRISMA C-REACTIVE PROTEIN CONTROLS?

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

What is the FDA product code for PRISMA C-REACTIVE PROTEIN CONTROLS?

The FDA product code for PRISMA C-REACTIVE PROTEIN CONTROLS is DCK.

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 Syva Co. as applicant

K011878EMIT (R) TOX SALICYLIC ASSAY, MODEL 7SO19UL, EMIT (R) TOX SALICYLIC ACID CALIBRATORS, MODEL 7S109UL K012257EMIT II PLUS MONOCLONAL AMPHETAMINE/METHAMPHETAMINE ASSAY MODEL OSR9C229 K011947EMIT 2000 VALPROIC ACID ASSAY, MODEL OSR4G229UL K011528EMIT 2000 PHENOBARBITAL ASSAY, MODEL OSR4D229 K011347EMIT 2000 PHENYTOIN ASSAY, MODEL 0SR4A229 K993980SYVA EMIT II PLUS ETHYL ALCOHOL ASSAY, MODELS 9K309UL/9K409UL

View all 448 devices →

Related Devices (Code: DCK)

K242170K-ASSAY CRP (Ver.2)Kamiya Biomedical Company, LLC K201256Procise CRP, ProciseDx Analyzer, ProciseDx Calibration CartridgeProcise Diagnostics K192028Yumizen C1200 CRPHORIBA ABX SAS K192118CRP VarioSENTINEL CH. SpA K191993Yumizen C1200 CRPHORIBA ABX SAS K160712VITROS Chemistry Products hsCRP ReagentOrtho Clinical Diagnostics

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.