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)

CK-TOTAL/CK-B (NAC) BIOLUMIN. ASSAY KIT

K-Number: K810853 · 1981-05-29

ApplicantThe Upjohn Co.
Decision Date1981-05-29
Product CodeCGS
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

CK-TOTAL/CK-B (NAC) BIOLUMIN. ASSAY KIT is the device name listed in this FDA 510(k) record. The listed applicant is The Upjohn Co.. It received FDA 510(k) clearance on 1981-05-29 under 510(k) number K810853. The device is classified under product code CGS. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CK-TOTAL/CK-B (NAC) BIOLUMIN. ASSAY KIT?

CK-TOTAL/CK-B (NAC) BIOLUMIN. ASSAY KIT is a medical device that received FDA 510(k) clearance on 1981-05-29. The listed applicant is The Upjohn Co.. The 510(k) number is K810853.

When did CK-TOTAL/CK-B (NAC) BIOLUMIN. ASSAY KIT receive FDA 510(k) clearance?

CK-TOTAL/CK-B (NAC) BIOLUMIN. ASSAY KIT received FDA 510(k) clearance on 1981-05-29, under 510(k) number K810853.

Who is the listed applicant for CK-TOTAL/CK-B (NAC) BIOLUMIN. ASSAY KIT?

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

What is the FDA product code for CK-TOTAL/CK-B (NAC) BIOLUMIN. ASSAY KIT?

The FDA product code for CK-TOTAL/CK-B (NAC) BIOLUMIN. ASSAY KIT is CGS.

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 The Upjohn Co. 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.

K902004TROBICIN SUSCEPTIBILITY POWDERK900455ZEFAZONE SUSCEPTIBILITY POWDERK782009RIA KIT, PROGESTERONEK780792TESTOSTERONE RADIOIMMUNOASSAY KIT 125IK760920CAT-A-KIT

Related Devices (Code: CGS)

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.

K191296Pointe Scientific Creatinine Kinase (CK) Reagent SetMedtest DXK182702SEKURE Creatine Kinase AssaySekisui Diagnostics P.E.I., Inc.K160724ADVIA Chemistry Creatine Kinase (CK_L) Assay, ADVIA Chemistry Enzyme 3 CalibratorSiemens Healthcare Diagnostics, Inc.K123977RANDOX LIQUID CK-MB, RANDOX CK-MB CALIBRATORRandox Laboratories, Ltd.K112416CPK REAGENTVital Diagnostics (Manufacturing) PtyltdK083465DIMENSION VISTA CREATINE KINASE FLEX REAGENT CARTRIDGE AND DIMENSION VISTA CREATINE KINASE MB FLEX REAGENT CARTRIDGESiemens Healthcare 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.

↑