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)

UNITEST CREATINE KINASE

K-Number: K782156 · 1979-03-02

ApplicantBoehringer Mannheim Corp.
Decision Date1979-03-02
Product CodeJLB
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

UNITEST CREATINE KINASE is the device name listed in this FDA 510(k) record. The listed applicant is Boehringer Mannheim Corp.. It received FDA 510(k) clearance on 1979-03-02 under 510(k) number K782156. The device is classified under product code JLB. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the UNITEST CREATINE KINASE?

UNITEST CREATINE KINASE is a medical device that received FDA 510(k) clearance on 1979-03-02. The listed applicant is Boehringer Mannheim Corp.. The 510(k) number is K782156.

When did UNITEST CREATINE KINASE receive FDA 510(k) clearance?

UNITEST CREATINE KINASE received FDA 510(k) clearance on 1979-03-02, under 510(k) number K782156.

Who is the listed applicant for UNITEST CREATINE KINASE?

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

What is the FDA product code for UNITEST CREATINE KINASE?

The FDA product code for UNITEST CREATINE KINASE is JLB.

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 Boehringer Mannheim Corp. 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.

K984326ELECYS IGE ASSAYK983047ACCU-CHEK HQ SYSTEMK984419ELECSYS IGE CALCHECKK984425MODIFICATION OF PRECISET SERUM PROTEINS CALIBRATORK984372ELECSYS CALCHECK TROPONIN TK984105ELECSYS TROPONIN T STAT TEST

View all 340 devices →

Related Devices (Code: JLB)

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.

K992140PICCOLO METLYTE 7 REAGENT DISCAbaxis, Inc.K971817OLYMPUS CK-MB REAGENTOlympus America, 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.

↑