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)

QUANTAFFIRM CPK ISO ENZYME SERUM (HUMAN)

K-Number: K791723 · 1979-10-01

ApplicantOrganon, Inc.
Decision Date1979-10-01
Product CodeJJT
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

QUANTAFFIRM CPK ISO ENZYME SERUM (HUMAN) is the device name listed in this FDA 510(k) record. The listed applicant is Organon, Inc.. It received FDA 510(k) clearance on 1979-10-01 under 510(k) number K791723. The device is classified under product code JJT. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the QUANTAFFIRM CPK ISO ENZYME SERUM (HUMAN)?

QUANTAFFIRM CPK ISO ENZYME SERUM (HUMAN) is a medical device that received FDA 510(k) clearance on 1979-10-01. The listed applicant is Organon, Inc.. The 510(k) number is K791723.

When did QUANTAFFIRM CPK ISO ENZYME SERUM (HUMAN) receive FDA 510(k) clearance?

QUANTAFFIRM CPK ISO ENZYME SERUM (HUMAN) received FDA 510(k) clearance on 1979-10-01, under 510(k) number K791723.

Who is the listed applicant for QUANTAFFIRM CPK ISO ENZYME SERUM (HUMAN)?

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

What is the FDA product code for QUANTAFFIRM CPK ISO ENZYME SERUM (HUMAN)?

The FDA product code for QUANTAFFIRM CPK ISO ENZYME SERUM (HUMAN) is JJT.

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 Organon, 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.

K950861RECONSTITUTION ACCESSOREISK853388MONOSTICON UNI-DOTK842314DUOCLON COLOR-CEPTK841525OREIA II B-HCG PREGNANCY TEST KITK841602ACCURATE BETA 30 PREGNANCY TEST KITK840650B-NEOCEPT 30

View all 41 devices →

Related Devices (Code: JJT)

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.

K090940SPOTCHECK BLOOD SPOT CONTROL, ASSAYEDAstoria-Pacific, Inc.K062751MODIFICATION TO QUANTIMETRIX CARDIASURE CARDIAC MARKERQuantimetrix Corp.K030768CLINIQA LIQUID QC CARDIAC MARKER CONTROL LEVELS 1, 2 & 3, TRI-LEVELCliniqa CorporationK030102ADVIA CENTAUR AND ACS:180 LIQUID CARDIAC MARKERS 1, 2, 3Bayer Healthcare, LLCK021498LIQUICHEK CARDIAC MARKERS CONTROL LT LEVEL 1, 2, 3, AND TRILEVELBio-RadK012656LIQUICHEK CARDIAC MARKERS CONTROL LT LEVEL 1,2,3, MODELS 646,647,648Bio-Rad

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.

↑