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)

PARAMAX ACID PHOSPHATASE REAGENT

K-Number: K840661 · 1984-04-04

ApplicantAmerican Dade
Decision Date1984-04-04
Product CodeCKB
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

PARAMAX ACID PHOSPHATASE REAGENT is the device name listed in this FDA 510(k) record. The listed applicant is American Dade. It received FDA 510(k) clearance on 1984-04-04 under 510(k) number K840661. The device is classified under product code CKB. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PARAMAX ACID PHOSPHATASE REAGENT?

PARAMAX ACID PHOSPHATASE REAGENT is a medical device that received FDA 510(k) clearance on 1984-04-04. The listed applicant is American Dade. The 510(k) number is K840661.

When did PARAMAX ACID PHOSPHATASE REAGENT receive FDA 510(k) clearance?

PARAMAX ACID PHOSPHATASE REAGENT received FDA 510(k) clearance on 1984-04-04, under 510(k) number K840661.

Who is the listed applicant for PARAMAX ACID PHOSPHATASE REAGENT?

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

What is the FDA product code for PARAMAX ACID PHOSPHATASE REAGENT?

The FDA product code for PARAMAX ACID PHOSPHATASE REAGENT is CKB.

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 American Dade 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.

K873051STRATUS(R) HFSH FLUOROMETRIC ENZYME IMMUNOASSAYK873171STRATUS(R) CK-MB FLUOROMETRIC ENZYME IMMUNOASSAYK873052STRATUS(R) HLH FLUOROMETRIC ENZYME IMMUNOASSAYK872789PARAMAX URINE/CSF CALIBRATORK872195DATA-FI DIMERTEST LATEX ASSAYK872196AQUEOUS BLOOD GAS/ELECTROLYTE CONTR LEV I,II & III

View all 149 devices →

Related Devices (Code: CKB)

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.

K053612DRI-STAT ACID PHOSPHATASE REAGENTBeckman Coulter, Inc.K023840ACID PHOSPHATASE ASSAY FOR THE ADVIA 1650Bayer Diagnostics Corp.K991010ACPAbbott Diagnostics Mfg., Inc.K981743OLYMPUS AU400 CLINICAL CHEMISTRY ANALYZEROlympus America, Inc.K974695COBRAS INTEGRA ACID PROSTATIC PHOSPHATASE (ACPP) COBAD INTEGRA BENZODIAZEPINES WITH B-GLUCURONIDASE (BNZGL)Roche Diagnostic Systems, Inc.K963640OLYMPUS ACID PHOSPHATASE 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.

↑