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)

KALLESTAD QM300 C-REACTIVE PROTEIN ANTIBODY PACK

K-Number: K880728 · 1988-03-25

ApplicantKallestad Diag, A Div. of Erbamont, Inc.
Decision Date1988-03-25
Product CodeDCN
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

KALLESTAD QM300 C-REACTIVE PROTEIN ANTIBODY PACK is the device name listed in this FDA 510(k) record. The listed applicant is Kallestad Diag, A Div. of Erbamont, Inc.. It received FDA 510(k) clearance on 1988-03-25 under 510(k) number K880728. The device is classified under product code DCN. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the KALLESTAD QM300 C-REACTIVE PROTEIN ANTIBODY PACK?

KALLESTAD QM300 C-REACTIVE PROTEIN ANTIBODY PACK is a medical device that received FDA 510(k) clearance on 1988-03-25. The listed applicant is Kallestad Diag, A Div. of Erbamont, Inc.. The 510(k) number is K880728.

When did KALLESTAD QM300 C-REACTIVE PROTEIN ANTIBODY PACK receive FDA 510(k) clearance?

KALLESTAD QM300 C-REACTIVE PROTEIN ANTIBODY PACK received FDA 510(k) clearance on 1988-03-25, under 510(k) number K880728.

Who is the listed applicant for KALLESTAD QM300 C-REACTIVE PROTEIN ANTIBODY PACK?

The FDA 510(k) record lists Kallestad Diag, A Div. of Erbamont, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for KALLESTAD QM300 C-REACTIVE PROTEIN ANTIBODY PACK?

The FDA product code for KALLESTAD QM300 C-REACTIVE PROTEIN ANTIBODY PACK is DCN.

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 Kallestad Diag, A Div. of Erbamont, 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.

K910887QM300 CONTROL G PACKK910886QM300 ANTISTREPTOLYSIN O (ASO) ANTIGEN PACKK910885QM300 CALIBRATOR G PACKK904725CHLAMYDIA SYSTEM SOFTWARE (CSS)K902253PATHFINDER(TM) CHLAMYDIA MICROPLATE KITK902462MODIFIED QM300 RHEUMATOID FACTOR TEST

View all 58 devices →

Related Devices (Code: DCN)

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.

K232624CardioPhase® hsCRPSiemens Healthcare Diagnostic Products GmbHK221119RCRP Flex reagent cartridgeSiemens Healthcare Diagnostics, Inc.K192072Tina-quant C-Reactive Protein IVRoche Diagnostics Operations (Rdo)K180099Optilite High Sensitivity C-Reactive Protein KitThe Binding Site Group , Ltd.K172868Optilite C-Reactive Protein Reagent,Optilite C-Reactive Protein Calibrator,Optilite C-Reactive Protein ControlsThe Binding Site Group , Ltd.K171498MSD CRP Assay Kit and MESO SECTOR S 700 InstrumentMeso Scale Diagnostics, LLC

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.

↑