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)

ACID PHOSPHOTASE REAGENT TEST AND KIT

K-Number: K902543 · 1990-09-07

ApplicantCrestat Diagnostics, Inc.
Decision Date1990-09-07
Product CodeCKB
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ACID PHOSPHOTASE REAGENT TEST AND KIT is the device name listed in this FDA 510(k) record. The listed applicant is Crestat Diagnostics, Inc.. It received FDA 510(k) clearance on 1990-09-07 under 510(k) number K902543. 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 ACID PHOSPHOTASE REAGENT TEST AND KIT?

ACID PHOSPHOTASE REAGENT TEST AND KIT is a medical device that received FDA 510(k) clearance on 1990-09-07. The listed applicant is Crestat Diagnostics, Inc.. The 510(k) number is K902543.

When did ACID PHOSPHOTASE REAGENT TEST AND KIT receive FDA 510(k) clearance?

ACID PHOSPHOTASE REAGENT TEST AND KIT received FDA 510(k) clearance on 1990-09-07, under 510(k) number K902543.

Who is the listed applicant for ACID PHOSPHOTASE REAGENT TEST AND KIT?

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

What is the FDA product code for ACID PHOSPHOTASE REAGENT TEST AND KIT?

The FDA product code for ACID PHOSPHOTASE REAGENT TEST AND KIT 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 Crestat Diagnostics, 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.

K980883N-ASSAY GLU-ULK981276N-ASSAY L D-BILK981289N-ASSAY L T-BILK980900N-ASSAY CPK-LK980902N-ASSAY L AST/GOTK972257N-ASSAY TIA ANTITHROMBIN III TEST KIT

View all 29 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.

↑