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)

CARESIDE CKMB

K-Number: K990434 · 1999-04-19

ApplicantCareside, Inc.
Decision Date1999-04-19
Product CodeJHS
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

CARESIDE CKMB is the device name listed in this FDA 510(k) record. The listed applicant is Careside, Inc.. It received FDA 510(k) clearance on 1999-04-19 under 510(k) number K990434. The device is classified under product code JHS. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CARESIDE CKMB?

CARESIDE CKMB is a medical device that received FDA 510(k) clearance on 1999-04-19. The listed applicant is Careside, Inc.. The 510(k) number is K990434.

When did CARESIDE CKMB receive FDA 510(k) clearance?

CARESIDE CKMB received FDA 510(k) clearance on 1999-04-19, under 510(k) number K990434.

Who is the listed applicant for CARESIDE CKMB?

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

What is the FDA product code for CARESIDE CKMB?

The FDA product code for CARESIDE CKMB is JHS.

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 Careside, 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.

K020484CARESIDE LDHK020486CARESIDE GGTK020487CARESIDE ALTK020488CARESIDE TRGLYCERIDEK002792CARESIDE CHOLINESTERASEK001462CARESIDE HEMOGLOBIN

View all 22 devices →

Related Devices (Code: JHS)

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.

K160570Creatine KinaseRoche Diagnostics Operations (Rdo)K102706CKMB UDR ASSAYSENTINEL CH. SpAK082226S40 CREATINE KINASE (CK)Alfa Wassermann Diagnostic Technologies, Inc.K062128THE DIMENSION VISTA FLEX REAGENT CARTRIDGES / KIT ASSAYSDade Behring, Inc.K990439CARESIDE CKCareside, Inc.K981495IMMULITE CK-MB, CATALOG # LKCP1 (100 TESTS), LKCP5 (500 TESTS)Diagnostic Products Corp.

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.

↑